Managing FDA 483s: Before, During and After the Inspections
The FDA Form 483 represents an inspectional record of objectionable conditions observed by the FDA investigator during an inspection of a manufacturing establishment. The inspection will cover a certain set of regulations that apply to the particular manufacturer's operations. Products regulated by FDA have different manufacturing, records and reporting regulations.
The FDA investigator's job is to document examples of where a manufacturer does not appear to conform to FDA's regulations. The investigator collects evidence as examples of problems. The 483 items are discussed with the manufacturer during the inspection, but most importantly in a complete recitation with the discussion with management at the conclusion of the inspection.
How a firm interprets and responds to a 483 plays a tremendous role in its regulatory posture with FDA. The 483 and the supporting evidence provides FDA the basis to decide whether or not to take an administrative action, such as issuing a Warning Letter, or legal action, such a seizing products, begin to seek an injunction or prosecution.
Why Should you Attend: The FDA investigator starts looking at your problems before you ever see them at your front door. The 483s from your previous inspections give FDA a road map into your problems. The investigator will look at all of those prior "failures to comply." The investigator is already armed. When the investigator shows up at your front door, your complaint files become another roadmap into your problems. They start the trail of evidence the investigator will follow to show how bad you are as that evidence builds your new 483. Your job to mitigate the impact of the FDA 483 is at hand. Can you explain why a problem from the prior inspection was not effective? Can you explain why the investigator's current observation is not really as bad as it looks? What do you do with the mounting 483 items as the inspection continues? By now the investigator has a clear idea of what evidence is needed to solidify your inspectional profile. After the inspection, it is your job to explain the sins of your past and prove to FDA that you "get it" and will take prompt corrective action.
Your 483 picture before, during and after the inspections is a permanent record that can haunt your relationship with FDA for a long time. Maybe you are not able to convert a 483 in a picture book ending, but you can avoid becoming a disaster film.
Areas Covered in the Session:
- What is a 483 besides another government form?
- How and when the 483 is written
- How to effectively manage 483 items during an inspection
- How to interpret the 483
- How to respond verbally and in writing to FDA
- FDA's follow up inspection
Who Will Benefit:
- Regulatory Affairs
- Quality Assurance
- Manufacturing
- Complaint evaluation
- Public Relations and Sales
He developed enforcement actions and participated in the implementation of new statutory requirements. His comments are candid, straightforward and of practical value. He understands how FDA thinks, how it operates and where it is headed.
Based on his exceptionally broad experience and knowledge, he can synthesize FDA's domestic and international operational programs, institutional policy and thicket of legal variables into a coherent picture. Professional credentials: JD - Suffolk University, licensed in Massachusetts and the District of Columbia; M.Div in psychology - Boston University with internship through Harvard University.