FDA WARNING_LETTER - Vipor Chemicals Private Ltd. - February 24, 2018

The FDA issued Warning Letter 320-19-11 to Vipor Chemicals Private Ltd. following an inspection from February 21-24, 2018, at their Vadodara, Gujarat facility. The letter identifies significant deviations from current Good Manufacturing Practices (CGMP) for active pharmaceutical ingredients (API), rendering their drugs adulterated under 21 U.S.C. 351(a)(2)(B).

Key violations include: 1. **Failure to transfer all quality/regulatory information to customers:** Vipor Chemicals omitted the original API manufacturer's name and address (Basic Pharma Life Science Private Ltd., on Import Alert 99-32) from Certificates of Analysis (COA), compromising supply chain accountability. 2. **Lack of adequate procedures for quality and purity:** The firm lacked procedures for controlling, issuing, using, and reconciling batch manufacturing records (BMRs). Production activities were recorded in personal notebooks or draft BMRs, then transcribed and incinerated. There were also no procedures for investigating deviations, OOS/OOT results, or stability failures. 3. **Inadequate equipment cleaning procedures:** The cleaning procedure for API manufacturing equipment specified only water, without supporting data for its adequacy. Visible residue and rust were observed on equipment surfaces. 4. **Unvalidated water system:** The firm's water system, installed over four years prior, was not validated