FDA WARNING_LETTER - Foshan Flying Medical Products Co., Ltd. - February 23, 2017

The FDA issued a Warning Letter to Foshan Flying Medical Products Co., Ltd. following an inspection from February 20-23, 2017, identifying significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, rendering their drug products adulterated.

Key violations include: 1. **Inadequate Quality Control Unit (21 CFR 211.22(a) and (d))**: The firm lacked an adequate quality control unit, written procedures for numerous functions (e.g., complaints, deviations, investigations), and documentation for change control, annual product reviews, batch record review, and product approval/rejection. The quality unit consisted of a single production department employee for three years. 2. **Insufficient Release Testing (21 CFR 211.165(a) and (b))**: Finished drug products were released without adequate acceptance testing for identity, strength, or critical microbial attributes. 3. **Lack of Sterility Testing (21 CFR 211.167(a))**: A product labeled as "sterile" was marketed without performing sterility testing. 4. **Absence of Production and Process Control Procedures (21 CFR 211.100(a))**: The firm lacked an ongoing program for monitoring process control and process validation. 5. **Incomplete and Poorly Retained Batch Records (21 CFR