FDA WARNING_LETTER - Advanced Pharmaceutical Technology Inc. - August 01, 2024

On March 14, 2025, the FDA issued a Warning Letter to Advanced Pharmaceutical Technology Inc. following an inspection from July 10 to August 1, 2024, at their Elmsford, NY facility. The inspection revealed significant Current Good Manufacturing Practice (CGMP) violations for combination products, rendering their products adulterated under 21 U.S.C. 351(a)(2)(B). The company's products, including (b)(4), are considered drugs under 21 U.S.C. 321(g)(1).

Key violations include: 1. **Failure to prevent microbiological contamination (21 CFR 211.113(b)):** The firm lacked adequate controls for sterile products, relying on (b)(4) sterilization without pre-sterilization bioburden monitoring and failing to establish an adequate environmental monitoring system. This is a repeat violation from 2019 and 2021 inspections. 2. **Failure to determine satisfactory conformance to release rate specifications (21 CFR 211.167(c)):** The firm lacked adequate data to support dissolution claims for their (b)(4) products, which purport to have extended release effects. 3. **Failure to establish adequate production and process control procedures (21 CFR 211.100(a)):** The