Professional Compounding Centers of America dba PCCA

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Failure to promptly address these deviations and violations may result in legal action without further notice including, without limitation, seizure and injunction. Other Federal agencies may take your compliance history into account when awarding contracts.

Passage 2

Failure to address violations of FD&C Act sections may be cause for FDA to withhold issuance of Export Certificates and may be cause for FDA to withhold approval of new applications or supplements listing your firm as a drug manufacturer. We may re-inspect to verify that you have completed your corrective actions.