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The firm’s device history records were found to be incomplete, missing required information such as primary identification labeling for each production unit. Read More
GMP violations revealed during an FDA inspection include a lack of written procedures for design control, CAPA actions, and complaint handling. Read More
An FDA inspection at a medical device facility in Akita, Japan revealed nonconformities in process and software validation, as well as complaint handling and device history records. Read More
The FDA cited drug manufacturer Immunostics over CAPA procedure issues, inadequate complaint handling, calibration deficiencies and other problems at the firm’s Eatontown, New Jersey facility. Read More