BAMF Health, Inc.July 1, 2022

FDA 483 - BAMF Health, Inc. - July 01, 2022

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Record Details

An FDA inspection of BAMF Health Inc. in Grand Rapids, MI, from June 27 to July 1, 2022, revealed a significant deficiency in production and process controls. The firm failed to ensure consistent production of PET drugs meeting quality standards, specifically citing inadequate environmental monitoring during aseptic manufacturing operations.

Company: BAMF Health, Inc.
Inspection Date: July 1, 2022
Product Type: Drugs
Office: Division of Human and Animal Food Operations - East VI
People: Norman K. Starks
Courtney E. Hillier

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ID · 11425191-a700-4013-8a30-4c0d38873555