FDA WARNING_LETTER - Wuxi Medical lnstrument Factory Co., Ltd. - March 10, 2017

The FDA issued a Warning Letter to Wuxi Medical Instrument Factory following an inspection from March 6-10, 2017, identifying significant violations of current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, rendering their drug products adulterated. The firm's March 31, 2017, response was deemed insufficient.

Key violations include: 1. **Failure to establish written procedures for production and process controls (21 CFR 211.100(a))**: The firm failed to adequately validate the manufacturing process for their sterile (b)(4), lacking process qualification batch records and sufficient data. Commercial batch records also omitted critical process parameters. 2. **Failure to establish adequate laboratory controls (21 CFR 211.160(b))**: The firm did not perform growth promotion testing on each batch of microbiological growth media used for testing and lacked a written procedure for media preparation. 3. **Failure to clean, maintain, and sanitize equipment (21 CFR 211.67(a))**: Clean (b)(4) tubing was stored in an open container with exposed ends, risking contamination of terminally sterilized drug products, and procedures for maintaining, cleaning, and sanitizing this tubing were absent. 4. **Failure to maintain adequate written records of major equipment maintenance (21 CFR 211.182)**: Records for (