Wintac Limited – FDA Warning Letter, Sep 20, 2011

An FDA inspection of Wintac Limited's pharmaceutical manufacturing facility in Bangalore, India, from September 12-20, 2011, revealed significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated under 21 U.S.C. ? 351(a)(2)(B). The firm's October 11, 2011, response was deemed inadequate. Key violations included the failure to establish or follow appropriate written procedures to prevent microbiological contamination of sterile drug products, including validation of aseptic and sterilization processes (21 C.F.R. ? 211.113(b)), evidenced by inadequate smoke studies and poor aseptic practices. The firm also failed to thoroughly investigate batch failures or components not meeting specifications (21 C.F.R. ? 211.192), such as dropper-plugging problems. Furthermore, batch production and control records lacked complete information (21 C.F.R. ? 211.188(b)), specifically regarding undocumented torque deviations and aborted sterilization cycles. The FDA urged a comprehensive evaluation and remediation of the facility's documentation systems. Failure to correct these violations may result in the FDA withholding approval of new applications and refusing admission of products into the U.S. under 21 U.S.C. ? 381(a)(3). Wintac Limited must provide a written response within fifteen working days detailing corrective actions and supporting documentation.