FDA WARNING_LETTER - Sunstar Guangzhou Ltd. - June 28, 2019

The FDA issued a Warning Letter to Sunstar Guangzhou Ltd. following a June 24-28, 2019 inspection, citing significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, rendering their drug products adulterated. The firm's July 15, 2019 response to the FDA 483 was deemed inadequate.

Key violations include: 1. **Failure to test drug products before release (21 CFR 211.165(a)):** The firm released OTC drug products, including those for children, without testing for identity and strength of active ingredients like (b)(4). The response was inadequate as it lacked commitment to full testing, detailed procedures, or timelines. 2. **Failure to test incoming components (21 CFR 211.84(d)(1)):** The firm did not perform identity testing for incoming components, including active ingredients. 3. **Inadequate laboratory controls (21 CFR 211.160(b)):** The firm lacked scientific data for growth promotion procedures for microbiological testing of drug products and water. 4. **Inadequate Quality Control Unit (21 CFR 211.22(a) and 211.22(d)):** The Quality Unit failed to ensure adequate procedures and oversight, including control over batch records, proper data recording, and