FDA 483 - B&W TEK, Inc. - December 08, 2021

B&W TEK, Inc., a medical device manufacturer in Newark, DE, was cited for two observations during an FDA inspection. The firm failed to validate a manufacturing process according to established procedures, specifically lacking completion of a Performance Qualification study. Additionally, products not conforming to specifications were not adequately controlled, as an out-of-specification result was not evaluated for necessary investigation.