Norfolk Medical Products, Inc.July 26, 2022

FDA 483 - Norfolk Medical Products, Inc. - July 26, 2022

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Record Details

Norfolk Medical Products Inc, a medical device manufacturer in Skokie, IL, underwent an FDA inspection that identified a critical issue. The firm failed to document equipment calibrations, specifically for a heat sealer used in the manufacturing of sterilized needles. This lapse raises concerns about the integrity and sterility of their Class II medical devices.

Company: Norfolk Medical Products, Inc.
Inspection Date: July 26, 2022
Product Type: Device
Office: Chicago District Office
Person: Shafiq S. Ahadi (Investigator)

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ID · f8021711-cd6a-4725-84a7-e01ded32cd39