FDA WARNING_LETTER - Iso-Tex Diagnostics, Inc. - February 10, 2023

The FDA issued a Warning Letter to Iso-Tex Diagnostics, Inc. following an inspection from January 30 to February 10, 2023, 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). The firm's March 2, 2023, response to the Form FDA 483 was deemed inadequate. Key violations include the failure to maintain suitable buildings for drug manufacturing (21 CFR 211.42(a)), inadequate environmental monitoring and cleaning systems in aseptic processing areas (21 CFR 211.42(c)(10)(iv) & (v)), and failure to establish and follow appropriate written procedures to prevent microbiological contamination of sterile drug products, including validation of aseptic processes (21 CFR 211.113(b)). Additionally, the firm failed to establish adequate laboratory controls, evidenced by uncontrolled and expired testing materials (21 CFR 211.160(b)). The FDA noted repeat violations from previous inspections and a prior warning letter, indicating inadequate executive management oversight. The agency recommends engaging a qualified CGMP consultant to perform a comprehensive six-system audit. Iso-Tex Diagnostics must respond within 15 working days with corrective actions and prevention plans. Failure to promptly address these issues may result in regulatory actions such as seizure, injunction, and withholding of new drug approvals or export certificates.