FDA WARNING_LETTER - Wintac Limited - February 19, 2020

The FDA issued a Warning Letter to Wintac Limited following an inspection from February 10-19, 2020, identifying significant violations of current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, rendering their drug products adulterated.

Key violations include: 1. **Inadequate Investigations (21 CFR 211.192):** The firm failed to thoroughly investigate contaminated media fill units and other failures. Investigations lacked scientific justification, corrective and preventive actions (CAPA), and failed to assess all potentially compromised lots. A November 2019 media fill failure with *Ralstonia picketti* contamination was inadequately investigated, with a narrow focus and no CAPA. Similar deficiencies were noted in a June 2019 media fill investigation for a new aseptic filling line. The FDA requires a comprehensive, independent assessment of their investigation system, including improvements in competencies, root cause evaluation, CAPA effectiveness, and quality unit oversight, along with updated, independently evaluated media fill failure investigations for the past four years.

2. **Failure to Prevent Microbiological Contamination (21 CFR 211.113(b)):** The firm failed to establish and follow appropriate written procedures to prevent microbiological contamination, including validation of aseptic and sterilization processes. * **Inadequate Smoke Studies:** Smoke studies for aseptic processing lacked simulation of interventions and dynamic conditions, showing minimal protection, extensive manual interactions,