483
Babyation Inc.Babyation Inc. – FDA 483, May 28, 2026
Record Details
An FDA inspection of Babyation Inc., a manufacturer of Class II medical devices in Saint Louis, MO, revealed a significant issue regarding the verification of reworked products. The firm failed to adequately ensure that reworked medical device components met applicable acceptance criteria and regulatory requirements, specifically concerning cGMP compliance and comprehensive testing. This lapse could impact the safety and efficacy of distributed devices.
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