483
AdDent, Inc.AdDent, Inc. – FDA 483, Jul 24, 2026
Record Details
AdDent, Inc. in Danbury, CT, was cited for significant deficiencies in its quality system during an FDA inspection. The firm failed to maintain complete batch records, adequately assess design changes for regulatory impact, and properly manage supplier evaluations, alongside issues with purchased product verification and document control.
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ID · acd253e8-53f2-4b78-8a26-27c560743f06
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