FDA Most Common Drug and Device 483 Items

Updated July 30, 2024

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Inspection Observations - FDA.gov

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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