Diamond Chemical Co., Inc. – FDA Warning Letter, May 16, 2024

The FDA issued a Warning Letter to Diamond Chemical Co., Inc. following an inspection from May 6-16, 2024, identifying significant Current Good Manufacturing Practice (CGMP) violations for finished pharmaceuticals, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B). Key deficiencies include the firm's failure to test components for identity, purity, and quality, and to validate supplier test analyses (21 CFR 211.84(d)(1) and (d)(2)), specifically for ethanol, lacking a USP identification test for methanol. The company also failed to perform adequate laboratory determinations of final product conformance, including active ingredient identity and strength, prior to release (21 CFR 211.165(a)). Furthermore, the firm lacked established written procedures for production and process control (21 CFR 211.100(a)), evidenced by inadequate process validation for hand sanitizers and cleaning validation for non-dedicated equipment. An adequate written stability testing program was also absent (21 CFR 211.166(a)). Overall, the firm's quality systems were deemed inadequate. The FDA acknowledged the firm's commitment to cease manufacturing "FDA products" but requested clarification and a list of all drug products. If manufacturing resumes, the firm must engage a qualified CGMP consultant to conduct a comprehensive six-system audit and verify corrective actions. A written response detailing corrective actions is required within 15 working days, with potential regulatory actions for non-compliance.