FDA WARNING_LETTER - K.C. Pharmaceuticals, Inc. - February 13, 2026

K.C. Pharmaceuticals, Inc. received an FDA warning letter following an inspection conducted from January 20 to February 13, 2026, at its Pomona, California facility. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations under 21 CFR Parts 210 and 211, classifying the firm"s drug products as adulterated. Main violations centered on the failure to ensure product sterility and prevent microbiological contamination. The FDA noted unsuccessful media fills, poor aseptic techniques in sterile processing areas, and inadequate airflow visualization studies. Furthermore, the firm lacked robust visual inspection programs for identifying particulates in over-the-counter ophthalmic drugs and failed to maintain its purified water system. Laboratory deficiencies were also highlighted, including the absence of stability-indicating methods and improper equipment suitability testing. The Quality Unit was found to be ineffective in overseeing complaint investigations and stability programs. While the company has suspended production and initiated voluntary recalls, the FDA mandated several additional corrective actions. K.C. Pharmaceuticals must engage a qualified third-party consultant to perform a comprehensive six-system audit and oversee remediation. Required actions include performing a retrospective review of all media fills and complaints, conducting dynamic airflow studies, and establishing scientifically sound laboratory and stability programs. The firm must provide a detailed plan to ensure the Quality Unit has sufficient authority and must notify the FDA before attempting to resume manufacturing operations.