FDA 483 - Fomed Industries Inc. - July 11, 2019

An FDA inspection of Fomed Industries Inc., a medical device manufacturer in Qian Jiang City, Hubei, China, revealed significant deficiencies in their quality system. The firm failed to adequately establish procedures for design validation, control of nonconforming products, management review, and labeling activities. These issues indicate a broad lack of adherence to quality system requirements for medical device manufacturing.