FDA WARNING_LETTER - JHS Svendgaard Hygiene Products Ltd - August 22, 2019

The FDA inspected JHS Svendgaard Hygiene Products Ltd. in India from August 19-22, 2019, identifying significant violations of current good manufacturing practice (CGMP) regulations (21 CFR parts 210 and 211) for finished pharmaceuticals. Consequently, the firm's drug products are deemed adulterated under section 501(a)(2)(B) of the FD&C Act. Key violations included: failure to validate component supplier's test analyses (21 CFR 211.84(d)(2)); failure to establish and document the accuracy, sensitivity, specificity, and reproducibility of test methods, including lack of identity testing for finished products (21 CFR 211.165(e)); failure to establish adequate written procedures for production and process control, and lack of an adequate process validation program, including cleaning validation (21 CFR 211.100(a) and (b)); and the quality control unit's failure to ensure CGMP compliance, investigate deviations, and ensure stability testing (21 CFR 211.22). The FDA found the firm's responses inadequate, lacking specificity and retrospective assessment. The letter strongly recommends engaging a qualified CGMP consultant. The firm was placed on Import Alert 66-40, and failure to correct violations may lead to continued refusal of admission of products into the U.S. and withholding of new drug approvals. A written response detailing corrective actions is required within 15 working days.