Warning Letter - Regulatory Compliance Associates

The U.S. Food and Drug Administration (FDA) conducts on-site investigations for organizations that manufacture and package drugs to protect patient safety and maintain a high-quality standard in the life science industry. Both start-ups and enterprise pharmaceutical companies will be the subject of and FDA audit when any new product is launched.

What is a Warning Letter?

Conducting an FDA inspection may be necessary for your company to achieve compliance, which can pose challenges if you aren’t sure what is expected. If the FDA inspector observes conditions that violate the current regulatory standard, they may issue an FDA warning letter. Each warning letter includes detailed 483 observations for why your manufacturing facility is non-compliant. Your operations team will need to work with regulatory experts to prepare a response and action plan for FDA review and approval.

How many Pharma companies receive warning letters?

According to our partners at Redica Systems, the FDA sent at least 175 warning letters to small molecule drug and large molecule biologics manufacturers during fiscal 2023. Additionally, the regulatory compliance team at the FDA issued different types of warning enforcement & 483 observations that varied based on the corrective action and preventative action needed. Though receiving an FDA warning letter is not the end of the world, your company must understand the letter and respond appropriately with an action plan that returns your company to regulatory compliance.

Depending on your company’s regulatory response to the letter, the FDA may close out the investigation or take FDA 483 legal action if deemed necessary.

What is a Pre-Approval Inspection (PAI)?

Finally, it may be beneficial for your Quality Assurance team to conduct a FDA pre-approval inspection before a product comes to market to help refine standard operating procedures (SOP) for your quality management system (QMS).

Our PAI FDA clients have found this service to enhance their compliance many times over. RCA also can provide training for the FDA’s Pre-Approval Inspection (PAI) Program before the remediation efforts to help mitigate the situation. We adjust all our services to the needs of each client to help ensure the FDA’s concerns are addressed and compliance is achieved.

About RCA’s FDA Consulting Services

If the FDA issues you the unique types of FDA 483 warning letters, Regulatory Compliance Associates^® can assist in developing a response that will be accepted by the Agency and be realistic for your organization to execute. We can prepare a strategy and implementation program to help remediate the observations, as well as develop a comprehensive proof book.

Our list of services and programs to help with remediation efforts include:

FDA Form 483 Response
FDA Warning Letter Response
FDA Consent Decree Response
Import Bans and Notified Bodies Response
Independent Third-Party Oversight

RCA employs more than 500 industry experts, including FDA, Health Canada, and EU experienced regulatory affairs professionals, to provide support for life science companies. Using our knowledge of food and drug regulations, FDA policy and the pharmaceutical industry, we can help companies overcome unique regulatory challenges.

RCA has experience helping pharmaceutical companies respond to FDA warning letters and resolve compliance issues quickly. In one case, we helped a mid-sized company close out a 10-item 483 and subsequent warning letter in six months.

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

pharmaceutical consultants Regulatory 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 theee 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.

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