483
Cirtec Medical CorpFDA 483 - Cirtec Medical Corp - May 15, 2025
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Record Details
Cirtec Medical Corp in Brooklyn Park, MN, was cited for inadequate process validation during an FDA inspection. The firm's documentation for an implantable medical device component's manufacturing process failed to demonstrate consistent adherence to specified product requirements. This deficiency poses potential risks to patients, including infections, allergic reactions, and the need for additional surgery.
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ID · 3e91f851-8a37-487f-9d50-e0328b72fd74