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What is the difference between the FDA inspection observations and the inspection citations reports?

FDAcurious opened this issue · comments

commented
What is the difference between the FDA inspection observations and the inspection citations reports?
commented

Inspectors note observations (undesirable conditions) that are connected to specific regulation citations. For example, an inspection conducted at Oscar, Inc in August 2016 yielded a 483 (Inspectional Observations) with three noted observations. Observation 3: "Procedures for training and identifying training needs have not been adequately established." This observation is relevant to 21 CFR 820.25(b).

commented

Closing as this is beyond the scope of our work (and very old).