FDA 483 - Wuhu Nuowei Chemistry Co., Ltd - September 06, 2024

Wuhu Nuowei Chemistry Co., Ltd, a pharmaceutical manufacturer in Wuhu, Anhui, China, was inspected by the FDA and found to have significant deficiencies. The inspection revealed an inadequate quality control unit, failures in establishing and validating cleaning protocols for production equipment, and a lack of validation and verification for test methods used in manufacturing. These issues indicate a lack of adequate controls to ensure product quality and prevent contamination for products released to the USA market.