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Audifon-USA established inadequate procedures for complaint reviews, corrective and preventive actions, equipment calibration, and other activities, according to a Form 483. Read More
Orchid Orthopedics Solutions received a Form 483 after inspectors found that the company failed to validate computer software and properly document rework and re-evaluation activities. Read More
Hoggan Scientific LLC has been hit with a Form 483 after an inspection revealed a lack of adequate procedures for design control, corrective and preventive actions, complaint evaluation, and other issues. Read More