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Border Alerts

- - -
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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For drug products made outside the U.S. that do not comply with cGMPs or other FDA regulations, the FDA can issue a Border Alert that requires U.S. Customs to block that product's entry into the U.S.

For example, the FDA alerted customs about a drug not approved in the U.S.

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