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FDA 483
- - -
o cGMP enforcement
o Inspections
o Adulteration
o FDA 483
o Recall
o Warning Letter
o Border Alerts
o License Suspension or Revocation
o Seizure
o Consent Decree
o Criminal Prosecution

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 This is the form used by investigators to record their observations of non-compliance with cGMPs. While firms are not required to respond to 483's, it is considered prudent to do so, telling the FDA what will be done to correct not just the immediate, specific problem, but also the system(s) that are the root(s) of the problem.

Sample FDA observations from a Schering-Plough facility in Puerto Rico Portable Document Format
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