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Welcome

Enforcement: What Can Happen
- - -
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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Following cGMPs isn't optional.

All products -- prescription and over-the-counter -- available for use in the U.S. must be produced according to the FDA's cGMP regulations.
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