Mendell IncAugust 3, 2022

FDA 483 - Mendell Inc - August 03, 2022

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Record Details

Mendell Inc, a contract manufacturer in Lakeville, MN, was cited with a Form FDA-483 due to significant deficiencies in its quality system. The inspection revealed inadequate procedures for corrective and preventive actions, specifically concerning the verification of effectiveness and adherence to established timelines. Additionally, the firm failed to adequately maintain records of changes to documents.

Company: Mendell Inc
Inspection Date: August 3, 2022
Product Type: Device
Office: Minneapolis District Office
Person: Joseph D. Gong (issuing_officer)

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ID · e65cf465-e283-4c52-b227-2fc75f0fd8df