FDA 483 - K.C. Pharmaceuticals, Inc - February 13, 2026

K.C. Pharmaceuticals, Inc. received a Form 483 citing significant deficiencies across its sterile drug product manufacturing operations. Key issues include inadequate aseptic process validation, failed media fills, deficient environmental monitoring, and a lack of robust quality control oversight. The firm also failed to adequately investigate quality events, manage complaints, and ensure the suitability of its water system and testing methods.