FDA WARNING_LETTER - TAIWAN BIOTECH CO., LTD. - September 11, 2017

The FDA inspected Taiwan Biotech Company, Ltd. from September 1-11, 2017, identifying significant CGMP violations for finished pharmaceuticals, rendering their drug products adulterated.

Key violations include: 1. **Inadequate environmental monitoring (21 CFR 211.42(c)(10)(iv)):** The firm failed to investigate environmental monitoring plates exceeding action limits, lacked documentation for samples, and did not conduct required surface sampling or environmental sampling during specific production shifts for 1-2 years. Their response was deemed inadequate, lacking detailed remediation plans and retrospective analysis. 2. **Failure to follow stability testing program (21 CFR 211.166(a)):** The firm missed and delayed stability testing for drug products, without initiating investigations. Their response lacked a revised SOP and retrospective analysis of root causes. 3. **Inadequate annual product reviews (21 CFR 211.180(e)):** Annual product reviews only included batches shipped to the U.S., excluding other batches manufactured under the same conditions, hindering meaningful trend detection.

The FDA noted significant quality control unit deficiencies and data integrity lapses, questioning the accuracy and integrity of data. The firm is strongly recommended to engage a CGMP consultant for comprehensive remediation, including data integrity, environmental monitoring, investigations, and laboratory systems.

Corrective actions and timelines: The firm must respond within 15 working days