Warning Letter Remediation

In this episode of RCA Radio, host, Brandon Miller, and Regulatory Compliance Associates® Executive VP of Pharmaceuticals, Steven Lynn, go over how RCA helped an international company perform a gap analysis based on multiple FDA investigations.

Listen in as we break down the client’s Warning Letter Remediation challenges, RCA’s approach to remediation, the ongoing work still taking place, and some advice on FDA Investigation Readiness.


About RCA Warning Letter Services

To protect public safety and maintain a high standard of quality in the pharmaceutical industry, the U.S. Food and Drug Administration (FDA) conducts investigations into companies that manufacture and package drugs. Both small start-ups and large pharmaceutical companies may be the subjects of FDA investigations. If the inspector observes conditions that seem to violate FDA regulations, they may issue a pharmaceutical warning letter. 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.


Though receiving an FDA warning letter is not the end of the world, your company must understand the letter and respond appropriately. Conducting an FDA inspection may be necessary for you to achieve compliance, which can pose challenges if you aren’t sure what is expected of you.


What Happens After You Receive a 483 Inspection Observation or a Pharmaceutical Warning Letter

The FDA issues several types of letters to pharmaceutical companies. Depending on the situation, you may receive a Form 483, a warning letter or a consent decree. An FDA 483, which details a number of specific concerns, is issued after an investigation if an inspector sees conditions or practices they believe may violate the Food Drug and Cosmetic Act or other regulations. An FDA warning letter is issued to a company that has significantly violated FDA regulations and lays out a timeframe for corrections.


Whether you receive an FDA 483 or a warning letter, you are expected to develop a regulatory response to the FDA in writing. Included in your strategy will be an FDA Audit that addresses compliance issues through remediation as quickly and thoroughly as possible. Taking comprehensive action is essential to getting your company back on track. A well written FDA EIR is essential to proving concise and clear documentation for your activity. 


Resolving Compliance Issues at Your Company


If the FDA issues you the unique types of FDA 483 warning letters, Regulatory Compliance Associates® Inc. 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.


Preparing in Advance an FDA 483

RCA also can provide training for the FDA’s Pre-Approval Inspection (PAI) Program before the remediation efforts to help mitigate the situation. Our PAI FDA clients have found this service to enhance their compliance many times over. 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 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


pharmaceutical consultantsRegulatory 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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