FDA WARNING_LETTER - Sun Pharmaceutical Industries Ltd - May 09, 2022

The FDA issued an amended Warning Letter to Sun Pharmaceutical Industries Ltd. following an inspection from April 26 to May 9, 2022, at their Halol, India facility. The inspection revealed significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B). Key violations include failure to establish and follow procedures to prevent microbiological contamination of sterile drugs, with inadequate media fills (21 CFR 211.113(b)); failure to maintain adequate aseptic processing areas due to poor cleanroom design and environmental monitoring deficiencies (21 CFR 211.42(c)(10)); failure to use appropriately designed and maintained equipment, leading to extraneous matter contamination (21 CFR 211.63); inadequate investigations into discrepancies like cleanroom water leaks (21 CFR 211.192); and failure to adequately clean and maintain equipment (21 CFR 211.67(a)). The letter highlights an ineffective quality system, insufficient Quality Unit oversight, and poor internal communication of quality risks. The FDA strongly recommended engaging a CGMP consultant. The firm has discontinued certain manufacturing operations and recalled affected batches. The FDA placed the firm on Import Alert 66-40 and may withhold new application approvals or refuse product admission if deficiencies are not corrected. A written response detailing corrective actions is required within 15 working days, and a regulatory meeting is requested.