Bachem Americas, Inc.June 3, 2019

FDA 483 - Bachem Americas, Inc. - June 03, 2019

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Record Details

An FDA inspection of Bachem Americas, Inc. in Torrance, CA, revealed a significant deficiency in their quality system. The firm failed to adequately determine the cause of out-of-specification (OOS) test results, specifically in three reviewed investigations related to materials used in commercial API manufacturing. This indicates a moderate severity issue concerning quality control and investigation processes.

Company: Bachem Americas, Inc.
Inspection Date: June 3, 2019
Product Type: Drugs
Office: Division of Pharmaceutical Quality Operations IV
Person: Bryan A. Galvez (Pharmaceutical investigator)

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ID · 8bcb8500-97a7-496a-8f3f-be434585a7e2