483
C&A TOOLFDA 483 - C&A TOOL - March 02, 2022
Record Details
C&A Tool, a medical device manufacturer in Auburn, IN, was cited for five significant quality system deficiencies during an FDA inspection. The observations primarily concern inadequate procedures for process control, process validation, corrective and preventive actions, control of nonconforming product, and complaint handling. These issues indicate a systemic lack of established and followed quality management practices.
Open in Dashboard
ID · 75ba4fe0-8652-469d-8081-a445f62d6bdb