Bachem Americas, Inc.
FDA inspection history in Vista, California, 2017 to 2023
- 2
- Form 483s
Every document, by year
- Form 483
2017: one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2017One Form 483, at Vista, California.
- 2023One Form 483, at Vista, California.
- 2023The longest 483 on file: 4 observations over 6 pages at Vista, California.
Cited most
Across all Bachem Americas observations on file
- 21 CFR 211.22Responsibilities of quality control unit2
- 21 CFR 211.25Personnel qualifications1
- 21 CFR 211.48Plumbing1
- 21 CFR 211.56Sanitation1
- 21 CFR 211.68Automatic, mechanical, and electronic equipment1
The complete Bachem Americas file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Vista, California
Two Form 483s · 2017 to 2023 · 6 observations
Latest: Form 483, Mar 27, 2023 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-03-27 | 483 Form 483 | Vista, California | 4 | $99 |
| 2017-02-10 | 483 Form 483 | Vista, California | 2 | $99 |
Investigators on these documents
FEI number 3000718309 · most recent document Mar 27, 2023
About Bachem Americas, Inc.
How many FDA Form 483s has Bachem Americas, Inc. received?
FDA Intel has 2 Form 483s on file for Bachem Americas, Inc.; the most recent is dated Mar 27, 2023.
When was Bachem Americas, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Bachem Americas, Inc. is a Form 483 dated Mar 27, 2023, for the site in Vista, California.
What did FDA cite at Bachem Americas, Inc.?
The regulations cited most in the observations on file for Bachem Americas, Inc. are 21 CFR 211.22 (Responsibilities of quality control unit), 2 times; 21 CFR 211.25 (Personnel qualifications), 1 time; 21 CFR 211.48 (Plumbing), 1 time.