483
Mendell IncMendell Inc – FDA 483, May 30, 2025
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.
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ID · d52f3183-602a-45df-8886-a68cfd314cfe
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