FDA WARNING_LETTER - Kilitch Healthcare India Limited - October 20, 2023

On March 28, 2024, the FDA issued Warning Letter 320-24-29 to Kilitch Healthcare India Limited following an inspection from October 12-20, 2023. The facility's drug products are deemed adulterated under 21 U.S.C. 351(a)(2)(B) due to significant Current Good Manufacturing Practice (CGMP) violations and under 21 U.S.C. 351(a)(2)(A) due to insanitary conditions.

Key violations include: 1. **Insanitary Conditions:** The facility was in disrepair, poorly cleaned, and maintained, with unaddressed residue and inadequate microbiological impact evaluations. 2. **CGMP Violations:** * **Aseptic Processing:** Failure to prevent microbiological contamination (21 CFR 211.113(b)) due to poor aseptic practices, inadequate media fill programs that did not simulate commercial operations, and deficient smoke studies showing turbulent airflow. * **Laboratory Records:** Failure to ensure complete data (21 CFR 211.194(a)), including fabrication and alteration of environmental and personnel monitoring results, and non-contemporaneous record completion. * **Facility Control:** Failure to maintain defined areas to prevent contamination (21 CFR 211.42(c