Okay, let’s settle this once and for all. We wrote a series of posts that will give you an industry primer for what these Form FDA 483s are, why they’re important, how to avoid them, and how to respond to them.
Today, we cover the basics. Some of you pros out there know this stuff all too well…
What is a Form FDA 483?
The FDA has authority to inspect factories that manufacture products regulated by the FDA. FDA inspectors can come in and inspect any given facility at any time, and they essentially write down their observations on a form called Form FDA 483s (or just 483s for short). Read Wikipedia’s entry on 483s for more background.
What is IN a Form FDA 483?
The best way to tell you is to show you. Visit the FDA’s ORA FOIA reading room for a sample of 483s that the FDA makes available publicly. Basically, you’ll see these fields in a 483:
- Issuing FDA field office and address.
- Dates of inspections – can be as short as 1 day or as long as multiple weeks.
- FEI number – stands for the Firm Establishment Identifier, a number created by the corresponding district office.
- Manufacturer’s contact info (no fun being this person, right?)
- List of observations – typically, there’s somewhere between 5 and 10, though I’ve seen some with 58+ (ouch…).
- Names and titles of the investigators – usually 1 or 2. One unfortunate pharma manufacturer got to host 11 of them.
What’s the difference between a Form FDA 483 and a warning letter?
Inspections where investigators note observations that may be violations of regulations lead to Form FDA 483s. Warning letters are a notch higher than Form FDA 483s – they usually result from:
- Failure to adequately address the observations in issued 483s
- Unsatisfactory or incomplete corrective actions proposed by the sponsor
- Other issues that are much more serious and require quick attention/escalation
Essentially, by listing deficiencies in a warning letter, FDA has determined that the practice violates a regulation to which the firm must comply. Issuance of 483s tend not to make the press, whereas warning letters posted on the FDA website usually make the industry news section.
And so long as we’re getting all the terminology right, there’s 1 more report type to be aware of: the EIR (Establishment Inspection Report). This is a more detailed play-by-play description of the inspection, written by the inspector.
Think of the 483s as an executive summary of observations they made during the inspection (i.e., here’s the 10 key items) and the EIR as the inspector journal (i.e., “and then I talked to Peggy Smith, Associate Director of Regulatory Affairs, and she was responsive to our information requests”).
When should I respond to a Form FDA 483s?
Companies that receive a Form FDA 483 should respond within 15 days to have their responses considered before FDA takes additional enforcement action. If they do not, FDA will not consider their response in the decision on whether to escalate to a warning letter.
Learn more about how FDAzilla can help you achieve your quality and inspection preparation goals: get 483s, Inspector Profiles, Enforcement Analytics, and GMP Regulatory Intelligence. Contact us if you ever have questions at email@example.com.
*Updated in 2018 | Was originally posted in 2011.
About the Author
Tony Chen is Chairman and Co-Founder of FDAzilla, and served as Founding CEO from 2010 to 2017.
About the Author
Barbara W. Unger formed Unger Consulting, Inc. in December 2014 to provide GMP Quality consulting services to the pharmaceutical and biopharmaceutical industry. At Amgen, she led the segment of the Corporate GMP Audit group at Amgen focused on API manufacturers, Quality Systems and Computers. She developed, implemented and maintained the GMP Regulatory Intelligence program for 8 years at Amgen Inc. This included surveillance, analysis and communication of GMP related legislation, regulations, guidance and industry compliance enforcement trends. This was an essential service and tool within the Corporate Audit function.
Unger Consulting Inc. | www.ungerconsulting.net | 805.217.9360