Tag: FDA Remote Inspections

Since the Pandemic became global in 2020, the FDA has been requesting documents from firms in advance of or in lieu of an inspection. This authority comes from the Federal Food, Drug, and Cosmetic Act (FD&C Act) in Section 704(a)(4). However, while they have not adopted doing FDA inspections remotely instead of an onsite inspection, they have stated publicly they are considering the possibility, and virtual audits have become very common. 

 

FDA is still conducting onsite inspections and has submitted for new employee headcount in 2022 to reduce the existing backlog. Each inspection is carefully considered on a case-by-case basis where there is an imminent public health need. Factors such as risk to the FDA investigator and site personnel are also considered when determining if a virtual audit is appropriate.

 

Onsite inspections could be the standard inspection with the investigators staying in the facility the entire time or it could be a hybrid approach where the investigators spend some time in the facility and other time doing remote FDA reviews and conducting video interviews.

 

2022 will bring a new wave of inspections to the medical device and pharmaceutical industry. So how can you prepare in advance? And what does good look like from a virtual inspection process? Below are some thoughts for your team to consider.

 


Ready to Conduct a Mock Virtual Audit? Contact Us Now →


 

How Does an FDA Inspection Work?

 

FDA registrations simply don’t end and some health authorities outside the US have already done remote FDA inspections (e.g. the EMA). However, while the FDA has not done a true remote inspection, they have done many hybrid inspections.

 

What does an FDA inspection mean?

 

With the FDA format, regulatory authority tools include video chat for activities inside the interview room. They also use technology like secure shared online folders for offsite document review. Companies prepared to manage FDA inspections under this new method stand the best chance of success after an inspection to have fewer FDA 483 observations in general.

 

The FDA could start with a records request and then come onsite, or vice versa. Remember, if it is a true inspection the FDA must provide the most senior ranking person at the site a Notice of Inspection, Form FDA 482, at the very start of the inspection. If the Form 482 isn’t issued, then it is likely a records request utilizing their Section 704(a)(4) authorities.

 

FDA inspection

 

FDA record requests should follow the process and guidance outlined in their internal Staff Manual Guide, SMG 9004.1 Policy and Procedures for Requesting Records In Advance of or In Lieu of a Drug Inspection. Think of the SMG as an internal procedure for the FDA. If you are curious you can find it at this link: Staff Manual Guide 9004.1 (fda.gov)

 

 

Bottom line, if the FDA’s request comes through a call or email then it is not an inspection. It is a records request and should follow the procedures in SMG 9004.1. If they show up onsite, present a Form 482, then it is an inspection. Then the inspection could stay all onsite or it could be a hybrid approach, as noted above.  

 

Planning for an FDA Inspection

 

With the current pandemic, FDA has been providing a little advanced notice of the inspection, usually a few days to a week. The notice is directed less at giving companies time to prepare and instead intended to ensure the required personnel, who may be working offsite, are available. But prior planning precludes poor performance, so prepare well beforehand to manage a hybrid virtual inspection.

 

Some recommendations for inspection prep and readiness are as follows:

 

  • Determine who in the company will host the FDA inspection. Whether it’s onsite or virtual or hybrid you’ll want to designate a host. This distinction lets you train someone for the role, which helps streamline the process and eliminates last-minute challenges
  • Who will be the scribe and how will they take notes and communicate with the site team?
  • Determine who will step in as the back-up host and scribe in case the primaries are out sick.
  • Think through how the FDA inspection will flow, from the time it starts, through the facility tour, document requests and employee interviews.
  • If a virtual walk-through is conducted do you have sufficient Wi-Fi capabilities across the entire facility to avoid glitches in the audit and video.
  • How will you do the video? Use a phone camera or a real video camera.
  • Make sure you have the equipment ready to go and have tested it throughout the site.
  • How do you plan to maintain appropriate social distancing? Some companies have set up conference rooms complete with plexiglass barriers, tape markers on the floor and separated seating. In other cases, some activities are conducted outdoors, weather permitting.

 

Some additional helpful tips based on our experience with other clients are:

 

  • Collecting documents: This one can take a little time and it’s suggested that you start with the basics that you know the investigator will request, for example, a general site presentation, a batch record, deviation list, complaint list, facility layout, CAPA list, compliance documents, change controls and other master files.
  • Scanning and saving: Scan these documents ahead of time and upload them to an online company drive that is easily accessed by the inspection team.
  • Getting the right equipment: Whether you plan to use a smartphone or Wi-Fi camera, make sure the user knows how to operate it correctly and it works in every nook and cranny of your facility.
  • Running simulated inspections: A walkthrough lets you test video and audio quality. You can also identify and address poor Wi-Fi connectivity.

 

Virtual and hybrid inspections are a new format, and there can be challenges on both sides. Make sure your plan has some flexibility. Also, keep an eye on the FDA’s website for any announcements on virtual inspections. If the FDA does decide to start conducting virtual inspections it is likely that they will also roll out internal processes and procedures to ensure a harmonized approach. These items could be a Staff Manual Guide or a new chapter in their Investigations Operations Manual (Investigations Operations Manual | FDA).

 

About RCA’s Pharmaceutical Consulting Services 

 

Regulatory Compliance Associates (RCA) has helped thousands of pharmaceutical companies meet regulatory, compliance, quality assurance, and remediation challenges. With more than 20 years of experience with FDA, Health Canada, EU and global regulatory agencies worldwide, Regulatory Compliance Associates® offers leading pharmaceutical consultants. We’re one of the few pharma consulting companies that can help you navigate the challenges associated with industry regulations.

 

Our pharmaceutical consulting firm includes over 500 seasoned FDA, Health Canada & EU compliance consultants and regulatory affairs experts who understand industry complexities. It’s a pharma consultancy founded by regulatory compliance executives from the pharmaceutical industry. Every pharmaceutical industry consultant on the Regulatory Compliance Associates team knows the unique inner workings of the regulatory process. 

 

Client Solutions

 

Whether you’re in the product planning, development or pharmaceutical lifecycle management stage or need a remediation strategy for a compliance crisis, Regulatory Compliance Associates will guide you through every pharmaceutical consulting step of the regulatory process and create a customized approach depending on your product and your pharma company’s individual needs. Our regulatory compliance clients include:

 

  • Companies new to FDA, Health Canada or EU regulations and regulatory compliance
  • Start-up organizations with novel submissions to 510(k) submissions from multi-national corporations
  • Investment firms seeking private equity due diligence for pre-acquisition and post-deal research
  • Law firms seeking pharmaceutical consulting firm expertise in the remediation of warning letters, consent decrees, 483’s or import bans

 

Regulatory Affairs

 

Regulatory affairs is Regulatory Compliance Associates backbone. We exceed other pharma consulting companies with industry experts experienced in complexities of the pharmaceutical and biopharmaceutical industries. Our pharma consulting expertise spans all facets and levels of Regulatory Affairs, from Regulatory Support for New Products to Life Cycle Management, to other services like Outsourced Regulatory Affairs, Submissions, Training, and more.

 

As your partner, we can negotiate the potential assessment minefield of regulatory compliance services with insight, hindsight, and the clear advantage of our breadth and depth of knowledge and regulatory compliance consulting. We offer the following pharma consulting regulatory affairs services for pharmaceutical companies.

 

  • New Product Support
  • Product Lifecycle
  • Other Regulatory Services
  • Combination Products

 

Compliance Assurance

 

The regulations process surrounding pharmaceutical companies can be tricky for even the most experienced industry veteran to understand. Just one misstep could mean significant and lasting consequences for your business. At Regulatory Compliance Associates, we offer the pharma consulting experience and pharma consultants necessary to guide you through the quality compliance process.

 

  • Assessments
  • Audits
  • Regulatory Agency Response
  • Preparation and Training
  • Inspection Readiness
  • Data Integrity

 

Quality Assurance

 

Regulatory Compliance Associates Quality consulting includes assessments, strategy, implementations, staff augmentations, and identification of quality metrics to ensure continuous improvement. Our pharma consultants understand the strategic thinking needed to align your business needs and goals. Regulatory Compliance Associates quality assurance services include quality experts with experience spanning major corporations and start-ups. Our pharmaceutical consulting firm knows firsthand how to achieve, maintain, and improve quality, and we excel in transferring pharma consulting knowledge to your organization.

 

  • 21 CFR Part 11
  • Data Integrity
  • Manufacturing Support
  • Facility Support
  • Quality Metrics

 

Remediation Services 

 

Regulatory Compliance Associates has a proven remediation services approach to managing FDA Warning Letters, Consent Decrees, Remediation and other serious regulatory situations. Our pharma consultants know how to partner with executive, legal, and communication teams. Each RCA pharma consulting Expert will develop a response that will be accepted by the regulatory agency and be realistic to execute.

 

Regulatory Compliance Associates pharma regulatory consultants will develop a comprehensive proof book of documented evidence demonstrating the corrective action taken to remediate non-compliant issues. In addition, each Regulatory Compliance Associates pharma consulting Expert understands compliance enforcement. We’ll prepare a comprehensive pharma consulting strategy to assist in your remediation efforts, drive continuous improvement, and maintain regulatory compliance with the regulations.

 

  • Regulatory Action
  • Regulatory Compliance
  • Regulatory Enforcement
  • Warning Letter
  • 483 Observation
  • Oversight Services
  • Risk Management Plan

 

About Regulatory Compliance Associates

 

FDA inspectionRegulatory Compliance Associates® (RCA) provides pharmaceutical consulting to the following industries for resolution of life science challenges:

 

 

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.

 

As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

  • Founded in 2000
  • Headquartered in Wisconsin (USA)
  • Expertise backed by over 500 industry subject matter experts
  • Acquired by Sotera Health in 2021

 

About Sotera Health

 

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.

 

Sotera Health Company, along with its three best-in-class businesses – Sterigenics®Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.

 

We are a trusted partner to 5,800+ customers in over 50 countries, including 40 of the top 50 medical device companies and 9 of the top 10 pharmaceutical companies.

 

Commitment to Quality

 

Our Certificate of Registration demonstrates that our Quality Management System meets the requirements of ISO 9001:2015, an internationally recognized standard of quality.

 

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

 

 

The US Food and Drug Administration (FDA) is likely going to continue to use remote inspection alternatives in a “hybrid approach” with in-person inspections, supplemented by audit and FDA inspection tools like remote interactive assessments.

 

In a recent Accessible of Accessible Medicine’s (AAM) conference Elizabeth Miller, Assistant Commissioner in FDA’s Office of Medical Products and Tobacco Operations within the Office of Regulatory Affairs (FDA’s inspectorate) stated “Ideally, inspections supplemented by additional tools, including records requests and remote interactive evaluations, would provide FDA with the greatest depth of information”.

 

What is an FDA Inspection “Hybrid Approach”?

 

It is part onsite work and part offsite/remote work to conduct an assessment. The FDA uses tools like video chat for inspection activities like virtual interviews. They also use technology like secure shared online folders for offsite FDA 483 document review.

 

The FDA audit could start with a record request and then come onsite, or vice versa. Remember, FDA doesn’t consider remote evaluations to be a replacement for inspections. Inspections are onsite and will start with the lead FDA investigator providing the most senior ranking person at the site a Form FDA 482, Notice of Inspection.. The Form 482s is not issued for remote interactive evaluations.

 

Instead, your company will receive an FDA Form 4003, FDA Inspection Records Request. Having the term “inspection” in the title of the form can be a little confusing, but it is not considered or counts as an inspection. However, the FDA’s remote work will likely inform their onsite work during the actual inspection. Companies who prepare to manage these FDA  remote evaluations stand the best chance of success in an inspection. This is for all companies, whether you are conducting remediation because you’re having FDA compliance issues or not.


Need Help preparing for a Hybrid Inspection? Contact Us Now →


 

Will the FDA inspection changes be permanent?

 

Signs currently point to these changes moving down the path to permanency. FDA remote inspections and reviews can and do allow for more efficient onsite inspections. Conducting remote records reviews can help the investigators save time on site by not having to sit in a conference room and read. It also reduces their COVID exposure (and yours) by potentially reducing FDA facility inspection onsite time.

 

It must be pointed out that having a remote review does not immediately equate to a shorter onsite inspection. The onsite time will be dependent on what the investigator is covering and what they are or not finding. For example, an FDA GMP inspection may still take a different amount of time than a FDA surveillance inspection, and so on. 

 

The US Congress has even weighed in on the matter. For example, in a March 2021 Senate Health, Education, Labor and Pensions (HELP) Committee Hearing, Sen. Richard Burr, a member of the HELP Committee, suggested that the technology adoption for FDA virtual inspections should become more permanent in nature.

 

“The pandemic, I believe, has altered the model at FDA and the agency should not go back to its historical approach,” he said.

 

Risk-Based Model used to Identify FDA Inspections

 

The FDA’s risk-based criteria for prioritizing and selecting mission-critical inspections during the pandemic can be found in their Resiliency Roadmap for FDA Inspection Oversight. In the publication, they outline the factors helping to determine whether or not the inspection is mission-critical. These controls help FDA best utilize their already limited resources in protecting public health. The four specific factors the Agency is using are:

 

  • The product receiving a breakthrough therapy or regenerative medicine advanced therapy designation;
  • The product is used to treat a serious disease or medical condition and there is no substitute;
  • The product requires follow-up due to recall or there is evidence of serious adverse events or outbreaks of a foodborne illness; or
  • The product is related to the FDA’s COVID-19 response (e.g., drug shortages).

 

It is expected that this prioritization will be used during the remainder of the pandemic and that some will continue after travel restrictions and other impediments to inspections are eased or lifted.

 

FDA Inspection Hybrid Approach

 

Remote evaluations are time-consuming and take time to prepare and facilitate. Partner this with an onsite inspection and the time and effort quickly compound. Because of these activities are so time-consuming nature companies have had to improve how they efficiently and effectively manage these regulatory interactions.

 

One way to prepare is to look at your overall CGMP and quality system documentation and records to determine what needs to be scanned and uploaded to a secure shared folder prior to the start of the FDA remote review. The scanning process is time-consuming and if done ahead of time helps decrease the cycle time between the investigator’s request and the time you’ll have it ready to present to the investigator.

 

Another helpful hint is to ensure someone reviews the scanned file to ensure the entire document or record is scanned. With auto feeders on scanners, the dreaded folded page or previously stapled page getting jammed and not scanned properly is a common phenomenon. This can slow down any FDA pre-approval process meetings happening in real-time and can be avoided with focused preparation. 

 

The preparation effort can also assist you in being prepared for, as well as hosting your own hybrid internal audits (ex: corporate quality audits), as well as customer and notified body audits (if you’re in medical devices and deal with ISO 9001 and other ISO certification). 

 

What Our Experts Have to Say

 

Speculating on what the world might look like in terms of the use of alternative tools, industry representatives seemed in agreement that a hybrid approach would be most effective going forward.

Steven Lynn, RCA’s Executive Vice President of Pharmaceutical said:

 

“I don’t think the hybrid approach is going FDA Inspectionaway anytime soon. It just makes better sense from a public health efficiency perspective to be able to look at documents and records remotely and then go onsite.”

 

“If I look at it from an FDA perspective, the hybrid approach gives the Agency a way to ensure investigators can review items prior to putting boots on the ground. The remote reviews also enable the Agency to pull in other scientific disciplines easier than it would be, had the investigator been onsite. From the industry perspective, it means we must spend more time preparing in order to successfully host these remote reviews and onsite inspections.”

 

About RCA’s Pharmaceutical Consulting Services 

 

Regulatory Compliance Associates (RCA) has helped thousands of pharmaceutical companies meet regulatory, compliance, quality assurance, and remediation challenges. With more than 20 years of experience with FDA, Health Canada, EU and global regulatory agencies worldwide, Regulatory Compliance Associates® offers leading pharmaceutical consultants. We’re one of the few pharma consulting companies that can help you navigate the challenges associated with industry regulations.

 

Our pharmaceutical consulting firm includes over 500 seasoned FDA, Health Canada & EU compliance consultants and regulatory affairs experts who understand industry complexities. It’s a pharma consultancy founded by regulatory compliance executives from the pharmaceutical industry. Every pharmaceutical industry consultant on the Regulatory Compliance Associates team knows the unique inner workings of the regulatory process. 

 

Client Solutions

 

Whether you’re in the product planning, development or pharmaceutical lifecycle management stage or need a remediation strategy for a compliance crisis, Regulatory Compliance Associates will guide you through every pharmaceutical consulting step of the regulatory process. Our pharmaceutical consulting Experts will create a customized approach depending on your product and company’s individual needs. Our regulatory compliance clients include:

 

  • Companies new to FDA, Health Canada or EU regulations and regulatory compliance
  • Start-up organizations with novel submissions to 510(k) submissions from multi-national corporations
  • Investment firms seeking private equity due diligence for pre-acquisition and post-deal research
  • Law firms seeking pharmaceutical consulting firm expertise in the remediation of warning letters, consent decrees, 483’s or import bans

 

Regulatory Affairs

 

Regulatory affairs is Regulatory Compliance Associates backbone. We exceed other pharma consulting companies with industry experts experienced in complexities of the pharmaceutical and biopharmaceutical industries. Our pharma consulting expertise spans all facets and levels of Regulatory Affairs. Additionally, we specialize in Regulatory Support for New Products to Life Cycle Management, Outsourced Regulatory Affairs, Submissions, Training, and more.

 

As your partner, we can negotiate the potential assessment minefield of regulatory compliance services with insight, hindsight, and the clear advantage of our breadth and depth of knowledge and regulatory compliance consulting. We offer the following pharma consulting regulatory affairs services for pharmaceutical companies.

 

  • New Product Support
  • Product Lifecycle
  • Other Regulatory Services
  • Combination Products

 

Compliance Assurance

 

The regulations process surrounding pharmaceutical companies can be tricky for even the most experienced industry veteran to understand. Just one misstep could mean significant and lasting consequences for your business. At Regulatory Compliance Associates, we offer the pharma consulting experience and pharma consultants necessary to guide you through the quality compliance process.

 

  • Assessments
  • Audits
  • Regulatory Agency Response
  • Preparation and Training
  • Inspection Readiness
  • Data Integrity

 

Quality Assurance

 

Regulatory Compliance Associates Quality consulting includes assessments, strategy, implementations, staff augmentations, and identification of quality metrics to ensure continuous improvement. Our pharma consultants understand the strategic thinking needed to align your business needs and goals. Regulatory Compliance Associates quality assurance services include quality experts with experience spanning major corporations and start-ups. Our pharmaceutical consulting firm knows firsthand how to achieve, maintain, and improve quality. Finally, our regulatory compliance services team excels in transferring continuous improvement knowledge to your organization.

 

  • 21 CFR Part 11
  • Data Integrity
  • Manufacturing Support
  • Facility Support
  • Quality Metrics

 

Remediation Services 

 

Regulatory Compliance Associates has a proven remediation services approach to managing FDA Warning Letters, Consent Decrees, Remediation and other serious regulatory situations. Our pharma consultants know how to partner with executive, legal, and communication teams. Each RCA pharma consulting Expert will develop a response that will be accepted by the regulatory agency and be realistic to execute.

 

Regulatory Compliance Associates pharma regulatory consultants will develop a comprehensive proof book of documented evidence demonstrating the corrective action taken to remediate non-compliant issues. In addition, each Regulatory Compliance Associates pharma consulting Expert understands compliance enforcement. We’ll prepare a comprehensive pharma consulting strategy to assist in your remediation efforts, drive continuous improvement, and maintain regulatory compliance with the regulations.

 

  • Regulatory Action
  • Regulatory Compliance
  • Regulatory Enforcement
  • Warning Letter
  • 483 Observation
  • Oversight Services
  • Risk Management Plan

 

About Regulatory Compliance Associates

 

FDA InspectionRegulatory Compliance Associates® (RCA) provides pharmaceutical consulting to the following industries for resolution of life science challenges:

 

 

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.

 

As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

  • Founded in 2000
  • Headquartered in Wisconsin (USA)
  • Expertise backed by over 500 industry subject matter experts
  • Acquired by Sotera Health in 2021

 

About Sotera Health

 

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.

 

Sotera Health Company, along with its three best-in-class businesses – Sterigenics®Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.

 

We are a trusted partner to 5,800+ customers in over 50 countries, including 40 of the top 50 medical device companies and 9 of the top 10 pharmaceutical companies.

 

Commitment to Quality

 

Our Certificate of Registration demonstrates that our Quality Management System meets the requirements of ISO 9001:2015, an internationally recognized standard of quality.

 

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

 

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