FDA WARNING_LETTER - Glint Cosmetics Private Ltd - December 22, 2018

The FDA issued a Warning Letter to Glint Cosmetics Pvt. Ltd. following an inspection from December 17-22, 2018, citing significant violations of current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals (21 CFR, parts 210 and 211). The firm's drug products are deemed adulterated under section 501(a)(2)(B) of the FD&C Act.

Specific CGMP violations include: 1. **Quality Control Unit Failure (21 CFR 211.22):** The quality unit failed to ensure drug products comply with CGMP and meet specifications. The firm's response regarding hiring a consultant was deemed inadequate, lacking a comprehensive assessment and CAPA plan for QU effectiveness and oversight of products already on the market. 2. **Equipment Cleaning and Maintenance (21 CFR 211.67(a)):** The firm uses non-dedicated equipment without validated cleaning processes to prevent cross-contamination. Dried residue was observed on equipment and surfaces. Employees also pre-filled and falsified cleaning logbooks. The firm's response on dedicated scoops and cleaning frequency was insufficient, failing to address cross-contamination between different OTC drug products. 3. **Computer System Controls (21 CFR 211.68(b)):** Laboratory equipment and computers lacked restricted access, with shared logins and passwords. Electronic documents,