FDA WARNING_LETTER - Kor-Chem, Inc. - May 05, 2023

The FDA inspected Kor-Chem, Inc.'s drug manufacturing facility from April 26 to May 5, 2023, identifying significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B). The firm indicated it had "discontinued" drug products. Violations included failure to establish adequate written procedures for equipment cleaning and maintenance (21 CFR 211.67(b)), particularly concerning shared equipment with corrosive industrial chemicals, posing cross-contamination risks. The firm also failed to test component samples for identity, purity, strength, and quality (21 CFR 211.84(d)(1)), and failed to validate supplier test analyses (21 CFR 211.84(d)(2)), specifically for high-risk components like glycerin (DEG/EG) and ethanol (methanol). Additionally, the firm failed to conduct appropriate microbiological testing for each drug product batch (21 CFR 211.165(b)). The Quality Control Unit failed to ensure CGMP compliance and meet specifications (21 CFR 211.22), with deficiencies in process validation, water system validation, analytical method validation, and stability programs. The FDA requires a comprehensive remediation plan, including risk assessments for previously manufactured drugs, a CAPA plan for operations oversight, detailed component testing procedures, and a full assessment of the Quality Unit. The firm is advised to engage a CGMP consultant and respond within 15 working days to avoid further regulatory action.