Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistForcemech International LLC, a medical device manufacturer and repackager/relabeler of powered wheelchairs (Navigator and Navigator XL models), failed to comply with Current Good Manufacturing Practice (CGMP) requirements under the Quality System Regulation. During an inspection in March-April 2022, FDA found that the company did not adequately maintain device master records (DMRs) with required packaging and labeling specifications, specifically failing to document the coding system used to generate the 10-digit alphanumeric serial numbers on their devices. These deficiencies rendered the manufactured devices adulterated under section 501(h) of the Federal Food, Drug, and Cosmetic Act due to non-conformity with 21 CFR Part 820 requirements.