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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
Valeant received a warning letter for a high-precision compounding and dispensing device used to mix two solutions following an inspection that revealed a failure to maintain procedures for validating the device design. Read More