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1 extracted findings
FDA source excerpt, selected passage
Failure 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.
Findings and supporting evidence
Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.
Findings extracted from the letter
Selected FDA passages, not the complete letter.
01
Failure 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.
Source passage selected by the model
Sections and clauses cited
As cited in this historical letter, not a statement of current regulatory requirements.