Wednesday, December 30, 2009

FDA Most Common Drug and Device 483 Items

The AssurXblog post, The Most Common Drug and Device GMP 483 Items, reports 6 common FDA GMP drug 483 items, and 5 common FDA GMP medical device 483 items.

You'll want to read them all, and here are teasers from each category:

Drug GMP FDA-483 (observational) items:

  • Responsibilities and procedures of the Quality Control unit are not in writing
The most common Medical Device GMP FDA-483 (observational) items:
  • Deficiencies in complaint file system
Previous Posts:
FDA Says You Only Have 15 Days To Respond To Form 483
10 Tips - How to Avoid FDA 483 and Warning Letters
CAPA Problems - Most often cited 483 deficiency
FDA Says - Unwise To Ignore Form 483
Medical Device Sponsors - FDA Trends and Tips To Avoid 483s

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