The FDA issued a warning letter to Wilson Medicine Company citing serious quality problems found during a Feb. 26-March 1 inspection of its OTC manufacturing facility in Nandore, India.
During the inspection, the agency found the company failed to properly qualify its production process for OTC drug products and called for full documentation of equipment qualification protocols and timelines for all drug products distributed in the U.S. The agency also ordered a detailed summary of the firm’s approach to routine monitoring of intra- and inter-batch variation to maintain an ongoing state of control.
The facility also lacked proper validation and verification studies, and it’s response to the inspection findings were insufficient, the agency said. While the company committed to preparing a validation protocol, it did not specify a timeframe or provide an interim action plan.