Warning Letter Response

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 FDA 483 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 your company to achieve compliance, which can pose challenges if you aren’t sure what is expected.


FDA 483 & 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 Regulatory Compliance Associates


Regulatory Compliance Associates (RCA) provides FDA consultant services to the following industries for the resolution of compliance and regulatory 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
  • 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 more than 5,800 customers in over 50 countries, including 40 of the top 50 medical device companies and 8 of the top 10 pharmaceutical companies.



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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