FDA Inspection Classification Database Search - Free

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FDA Inspection Classification Database Search:   'via Blog this'

Wow! The FDA is disclosing inspection information to help improve the public’s understanding of how the FDA works to protect the public health. Disclosure of the compliance status of firms helps to provide the public with a rationale for the Agency’s enforcement actions and will also help to inform public and industry decision-making, allowing them to make more informed marketplace choices and help to encourage compliance.

In this inspections database, the FDA is specifically disclosing the final inspection classification for inspections conducted of clinical trial investigators, Institutional Review Boards (IRB), and facilities that manufacture, process, pack, or hold an FDA-regulated product that is currently marketed.

Have a go at it!

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Seven Strategies for Avoiding a 483

Updated January 18, 2017

The link in the original post broke.

You might also be interested in:
In-Person Ways to Avoid Form 483 Observations and Warning Letters - MDDI

- -  original post follows below  - -

Seven Strategies for Avoiding a 483:  'via Blog this'

"What a 483 is — and isn’t. After inspecting a food, drug, medical device, or biologic establishment, FDA prepares a written report of its inspection findings, following a debriefing. This report is intended primarily for internal FDA use and is not provided to the inspected institution at the conclusion of the on-site visit."

A nice, quick and easy primer on 483s.

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Will the FDA issue 10,000+ 483s in 2011?

FDA will issue 10,000+ 483s in 2011 – one every 52 minutes FDAzilla Blog:   'via Blog this'

The number is kind of shocking!  According to the FDAzilla Blog:

"Based on new data obtained by FDAzilla, the FDA should surpass 10,000 483s in 2011 for the second time in its history, breaking its all-time record for the third consecutive year."

According to e-How - The Definition of FDA 483:

FDA Form 483, is the form on which inspectors for the Food and Drug Administration detail unsatisfactory results of their inspection of manufacturing facilities for compliance with current good manufacturing practices (cGMP). The FDA inspects plants making human drugs (both prescription and over-the-counter drugs), animal and veterinary drugs, medical devices, food, radiation-emitting products, vaccines, blood and biological products and cosmetics for compliance with cGMP.

You might also be interested in:

Inspection Detection - a GMP training game by SkillsPlus Intl Inc.

An extensive library of 483 citation summaries from the FDA. Match the case with the corresponding 21 CFR 211 reference. Used as a classroom training tool or for self-study, this training aid challenges the student to identify and justify the 21 CFR 211 reference that supports the 483 citation.

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FDA - Final MDDS Rule - Federal Register Full-Text

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Updated August 7, 2023:

The original link broke.

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MDDS Rule - a webpage on FDA.gov

- - -  the original post follows below  - - -

The Food and Drug Administration (FDA), on its own initiative, is issuing a final rule to reclassify Medical Device Data Systems (MDDSs) from class III (premarket approval) into class I (general controls). MDDS devices are intended to transfer, store, convert from one format to another according to preset specifications, or display medical device data. MDDSs perform all intended functions without controlling or altering the function or parameters of any connected medical devices. An MDDS is not intended to be used in connection with active patient monitoring. FDA is exempting MDDSs from the premarket notification requirements. This rule is effective April 18, 2011.

Read the full-text of the MDDS rule in the Federal Register [Volume 76, Number 31 (Tuesday, February 15, 2011)].

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10 Tips - How to Avoid FDA 483 and Warning Letters

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Updated February 15, 2021

Links broke in the original post.

People also ask about:

Ten Most Common Reasons for FDA 483 Observations and Warning Letter Citations in Medical Device Environments - MasterControl

- - -  original post follows below  - - -

It never hurts to review or re-review your policies and procedures. 

Check out this white paper, Ten Most Common Reasons for FDA 483 Observations and Warning Letter Citations. 

Previous Posts: 

• CAPA Problems - Most often cited 483 deficiency 
• More FDA 483 Resources - Comments and Pearls from Validation Online 
• FDA 483 Inspectional Observations - learn from these examples 

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CAPA Problems - Most often cited 483 deficiency

You'll do well by reading this well-written article by Barbara Immel, "Converting CAPA to an Advantage - CAPA violations still generate a substantial number of warning letters. These tips can help make CAPA systems a benefit instead of a liability." Her writings are packed full of great content. Don't miss out on these pearls of wisdom and well referenced article.

In concluding, she writes, "CAPA deficiencies are one of the most common items cited in warning letters to medical device manufacturers. Therefore, it is critical for manufacturers to understand how to develop a CAPA system and how best to use it. . . ."

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