Bachem Americas, Inc.December 10, 2019

FDA 483 - Bachem Americas, Inc. - December 10, 2019

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Record Details

Bachem Americas, Inc. in Torrance, CA, an API manufacturer, received a Form 483 for deficiencies in their operations. The inspection revealed incomplete batch production records, insufficient investigation into purified water system contamination, and inadequate qualification of contract laboratories. These observations highlight concerns regarding documentation, quality control, and supplier management.

Company: Bachem Americas, Inc.
Inspection Date: December 10, 2019
Product Type: Drugs
Office: Division of Pharmaceutical Quality Operations IV
Person: Rumany C. Penn (Compliance Officer)

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ID · faf07fe9-f67c-4c30-8ca8-5e73658d8174