483
Bachem Americas, Inc.Bachem Americas, Inc. – FDA 483, Jun 3, 2019
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.
View Company Profile
ID · 8bcb8500-97a7-496a-8f3f-be434585a7e2
Other documents for Bachem Americas, Inc.
- EIR - 2022-02-23
- 483 - 2019-12-10
- EIR - 2019-06-12
- 483 - 2018-11-20
- EIR - 2018-05-18
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.