FDA WARNING_LETTER - IDT Australia Ltd. - December 08, 2017

The FDA inspected IDT Australia Ltd. from December 4-8, 2017, identifying significant CGMP deviations for active pharmaceutical ingredients (API) and violations for finished pharmaceuticals (21 CFR parts 210 and 211), rendering drugs adulterated. Key violations include: failure to adequately investigate out-of-specification (OOS) results and implement corrective actions for API, and the quality unit's failure to ensure critical deviations were resolved, leading to release of microbiologically contaminated API. For finished drugs, the firm failed to establish adequate laboratory control mechanisms (21 CFR 211.160(b)), ensure complete laboratory records (21 CFR 211.194(a)) by not reporting non-conforming test results, and establish an adequate quality control unit (21 CFR 211.22(a)) with proper data review authority, leading to data integrity issues. The FDA deemed the firm's responses inadequate and strongly recommended retaining a qualified consultant for remediation. Required actions include a comprehensive investigation into data inaccuracies, a risk assessment, and a management strategy with detailed CAPA plans, root cause analysis, and interim/long-term measures. Failure to correct these issues may result in withholding new application approvals and refusal of product admission into the U.S. A response is required within 15 working days.