FDA Inspection
Bachem Americas, Inc.Bachem Americas, Inc. – FDA Inspection, Feb 10, 2017
Record Details
This FDA Inspection record concerns Bachem Americas, Inc., with an inspection on February 10, 2017, issued by the Los Angeles District Office, covering human drugs.
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ID · a95abb99-3ebd-47e8-b72f-60ded6910b3f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1003665
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.48(a)Plumbing System Defects
- 21 CFR 211.68(b)Computer control of master formula records
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Bachem Americas, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| May 20, 2026 | Not classified | Los Angeles District Office | |
| March 27, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 5, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 2, 2011 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| May 6, 2010 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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