Originitalia SRL – FDA Warning Letter, May 24, 2024

The FDA issued a Warning Letter to Originitalia SRL in Caldogno, Italy, following an inspection from May 20-24, 2024. The inspection revealed significant Current Good Manufacturing Practice (CGMP) violations for finished pharmaceuticals, rendering the firm's drug products adulterated under 21 U.S.C. 351(a)(2)(B). The firm's June 13, 2024 response to the FDA 483 was deemed inadequate due to a lack of supportive documentation and evidence of corrective actions. Originitalia SRL has announced a freeze on OTC production for 2024. Key violations include the failure to test component samples for identity and validate supplier COAs (21 CFR 211.84(d)(1) and 211.84(d)(2)), failure to perform adequate laboratory release testing for drug products prior to distribution (21 CFR 211.165(a)), failure to establish adequate written procedures for production and process control, including process validation and cleaning validation (21 CFR 211.100(a)), and failure to establish an adequate stability testing program (21 CFR 211.166(a)). The FDA noted an ineffective quality system, citing a lack of effective management oversight and an insufficiently empowered quality unit. The agency recommended engaging a qualified CGMP consultant to evaluate operations and assist with remediation, including a comprehensive six-system audit. Products from Originitalia SRL were placed on Import Alert 66-40 on October 1, 2024. Failure to correct violations may lead to continued import refusal and withholding of new drug application approvals. A written response detailing corrective actions is required within 15 working days.