FDA 483 - Nesher Pharmaceuticals (USA) LLC - July 31, 2019

An FDA inspection of Wesher Pharmaceuticals (USA) LLC in Bridgeton, MO, a drug manufacturer, revealed significant deficiencies in quality control and manufacturing processes. The firm failed to thoroughly investigate out-of-specification and out-of-trend stability results for Oseltamivir Phosphate for Oral Suspension, lacked adequate written procedures for production equipment, and did not adhere to its established stability testing program. These issues indicate a lack of robust controls over drug product quality and purity.