Azer Scientific, Inc.December 4, 2023

FDA 483 - Azer Scientific, Inc. - December 04, 2023

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Record Details

An FDA inspection of Azer Scientific, Inc. in Morgantown, PA on December 4, 2023, revealed a significant deficiency in their quality system. The firm failed to adequately maintain complaint files, specifically lacking documented investigations for customer complaints involving foreign material and adverse events related to their glucose products. This indicates a serious lapse in their complaint handling procedures.

Company: Azer Scientific, Inc.
Inspection Date: December 4, 2023
Product Type: Device
Office: Philadelphia District Office
Person: Brian S. Keefer (Investigator at US Food and Drug Administration)

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ID · 4f80a501-3f4e-4f32-929e-76429736476e