FDA WARNING_LETTER - KENIL HEALTHCARE PRIVATE LIMITED - December 11, 2024

On June 12, 2025, the FDA issued a Warning Letter to Kenil Healthcare Private Limited, following an inspection from December 5-11, 2024, at their drug manufacturing facility in Gujarat, India. The letter identifies significant violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR parts 210 and 211), rendering their drug products adulterated under section 501(a)(2)(B) of the FD&C Act.

Key violations include: 1. **Failure to adequately clean and maintain equipment and facilities (21 CFR 211.67(a))**: Investigators observed mold, dirt, soiled air handling units, and product buildup in filling rooms and on equipment. The firm lacked validated cleaning procedures and proper documentation. The FDA deemed the firm's response inadequate, citing a lack of supporting data and failure to assess the impact on distributed products. 2. **Inadequate facility space to prevent mix-ups and contamination (21 CFR 211.42(b))**: Employees performed manual packaging on the floor, multiple drug products were packaged simultaneously without adequate separation, and reserve samples were improperly stored and commingled with expired products. The firm's response regarding warehouse expansion and updated procedures was deemed insufficient for interim controls. 3. **Quality Control Unit failure to ensure CGMP compliance (21 CFR 2