Advanced Pharmaceutical Technology
FDA issued a warning letter to Advanced Pharmaceutical Technology (Elmsford, NY) following a July–August 2024 inspection that found significant repeat CGMP violations at their combination product drug manufacturing facility. Key violations included failure to prevent microbiological contamination of purportedly sterile drug products, lack of adequate dissolution/release testing for controlled-release dosage forms, insufficient process validation, and an inadequate quality control unit that failed to oversee contract testing and manufacturing organizations. FDA warned that failure to correct these violations may result in seizure, injunction, withholding of export certificates, and denial of new drug application approvals, and required a written response within 15 working days.
Flagged claims (2)
your (b)(4) products, (b)(4), as well as your (b)(4) injection product are listed in FDA's electronic Drug Registration and Listing System (eDRLS) as "Export Only." However, information obtained during the inspection of your firm indicates that your firm plans to distribute these products commercially in the United States.
you claim your (b)(4) lasts for up to (b)(4) and that your (b)(4) products have (b)(4) effect for (b)(4)
Required actions (5)
After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence.
Failure to promptly and adequately address this matter may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.
Failure to address violations may also cause FDA to withhold issuance of Export Certificates. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP.
We may re-inspect to verify that you have completed corrective actions to address any violations.
Because you failed to correct repeat violations, you should engage a consultant qualified as set forth in 21 CFR 211.34 to assist your firm in meeting CGMP requirements.
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