Boehringer Ingelheim Fremont, Inc.November 4, 2022

FDA 483 - Boehringer Ingelheim Fremont, Inc. - November 04, 2022

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Record Details

An FDA inspection of Boehringer Ingelheim Fremont, Inc. from October 25 to November 4, 2022, revealed significant deficiencies in the firm's quality control unit. The inspection found that procedures for logbook review and deviation documentation were not adequately written or followed. Additionally, process description documents contained non-quantitative statements allowing for undocumented transient excursions from operating parameters.

Company: Boehringer Ingelheim Fremont, Inc.
Inspection Date: November 4, 2022
Product Type: Other
Office: Division of Human and Animal Food Operations - West V
People: Jeffrey P. Raimondi (Consumer Safety Officer)
Christopher R. Czajka (Consumer Safety Officer (Inspector))

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ID · 9e6e4169-d682-4b30-8ddd-4857a586bbf4