Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1Failure to address violations of the FD&C Act may be cause for FDA to withhold approval of requests for export certificates and approval of pending new drug applications or supplements listing your facility as a supplier or manufacturer.
Citations in the original letter
As cited in this historical letter, not a statement of current regulatory requirements.
- 21 CFR 201.128
- 21 CFR 3301