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FDA Issues Warning Letter to Advanced Pharmaceutical Technology for CGMP Violations
The U.S. Food and Drug Administration (FDA) issued a Warning Letter on 14 March 2025 to Advanced Pharmaceutical Technology following a July–August 2024 inspection at its Elmsford, New York facility. The FDA identified serious violations of Current Good Manufacturing Practice (CGMP) standards for combination drug products.
Key concerns included inadequate sterility controls, such as lack of pre-sterilization bioburden monitoring and insufficient environmental checks in sterile areas. The company also relied too heavily on final sterility testing without proper upstream safeguards.
Additional violations involved deficient dissolution testing, lack of process validation, and weak quality oversight. Notably, commercial batches were released without validated processes, and contract manufacturers were used without appropriate quality evaluation or oversight by the Quality Unit.
Due to repeated deficiencies from past inspections in 2019 and 2021, the FDA recommended engaging a qualified CGMP consultant and warned of potential regulatory actions.
Full details are available on the FDA website.
04-04-2025