FDA 483 - Mytamed Inc - June 27, 2022

Mytamed Inc, an initial distributor and importer in Malvern, PA, was inspected by the FDA, revealing two significant observations. The firm failed to adequately establish records for acceptable suppliers, including issues with their Approved Supplier List and supplier correspondence files. Additionally, Mytamed Inc did not perform quality audits at defined intervals, with no documentation of completed internal audits.