Mendell IncMay 30, 2025

FDA 483 - Mendell Inc - May 30, 2025

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Record Details

Mendell Machine and Manufacturing LLC, a manufacturer in Lakeville, MN, received a Form FDA-483 citing two observations. The firm failed to adequately establish procedures for corrective and preventive actions, specifically regarding documentation of CAPA effectiveness and risk assessments. Additionally, the company did not properly maintain records of changes to its critical inspection plans.

Company: Mendell Inc
Inspection Date: May 30, 2025
Product Type: Device
Office: Minneapolis District Office
Person: Albert L. Nguyen

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ID · d52f3183-602a-45df-8886-a68cfd314cfe