483
Design Specific, Ltd.FDA 483 - Design Specific, Ltd. - February 07, 2019
Record Details
An FDA inspection of Design Specific, Ltd., a medical device manufacturer in Laughton, revealed significant deficiencies in its quality system. The firm failed to establish or adequately implement procedures for design changes, purchasing and receiving, device history records, employee training, and internal quality audits. These issues indicate a systemic lack of control over critical manufacturing and quality assurance processes.
Open in Dashboard
ID · ba29fa42-ac2e-4232-bf72-149e5d1f344e