Tuesday, August 19, 2008

FDA 483 Inspectional Observations - learn from these examples

Here's a small collection of 483s (FDA Form 483 Inspectional Observations). If you've never seen one before, here's your chance. Take advantage of these to learn and share, so that you can avoid getting your own 483s. You can view these on the FDA's website, in the FDA Office of Regulatory Affairs (ORA) Electronic Reading Room. They display copies of ORA records. ORA makes these records publicly available either (1) proactively at their discretion or (2) because they are "frequently requested" per the Electronic Freedom of Information Act Amendments of 1996. Some records may be redacted to remove non-public information.

According to GMP Trends Inc., "an FDA 483 is a form used by an FDA investigator following an inspection of your plant. It lists deficiencies in your quality system and potential non-compliance issues with GMP's. These observations are based on the investigators interpretation of the GMP regulations as they apply to your specific situation. During the investigator's closing meeting with management, you may be given a Form 483." You can learn more about the FDA's thinking on 483s by reading this section from one of their manuals, FDA Investigations Manual - Reports of Observations.

These 483s can do several things for you. They'll:

  1. Get you more familiar with what a 483 is all about
  2. Give you the willies so you'll never want to earn your own 483s
  3. Provide examples that you can incorporate into your GMP training efforts
You might also be interested in:
Surviving An FDA Inspection - GMP Training - Taught by SkillsPlus International Inc.

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5 comments:

MG said...

A great site for 483s and many more FDA documents is:

https://library.compliancegurus.com/Default.aspx

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Avoiding FDA 483s said...

I totally agree - 483s are serious. With the recent increase in warning letters, 483s, and consent decrees, companies would be wise to respond as quickly, comprehensively, and logically as possible.

check out a new listing of FDA 483s:
http://www.fdazilla.com/fda/compliance/483/

it is a fully-searchable list of FDA 483s over the last 10 years.

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