FDA WARNING_LETTER - Vital Laboratories Pvt Ltd Plant II - April 06, 2017

The FDA inspected Vital Laboratories Private Limited Plant-II in Vapi, Gujarat, from April 3-6, 2017, identifying significant deviations from current Good Manufacturing Practice (CGMP) for active pharmaceutical ingredients (API), rendering them adulterated under 21 U.S.C. 351(a)(2)(B). The firm's April 27, 2017 response was deemed inadequate. Key violations included the failure to report, evaluate, and investigate production deviations; inadequate documentation of critical batch production steps with proper signatures; failure to adequately investigate and document out-of-specification (OOS) results and implement corrective actions; and the quality unit's failure to adequately perform annual product reviews (APR), including repeat errors. The letter highlighted repeated CGMP deviations across the company's network, indicating inadequate executive management oversight. The FDA strongly recommended engaging a qualified CGMP consultant. Vital Laboratories must conduct retrospective reviews of production records, batch records, OOS investigations, and APRs for all US-distributed drugs within expiry, perform risk assessments, and implement specific corrective and preventive actions. A written response detailing corrections and recurrence prevention is required within 15 working days. Failure to comply may result in FDA withholding approval of new applications and refusing admission of products into the U.S.