Bachem Americas, Inc.
FDA inspection history in Torrance, California, 2018 to 2019
- 3
- Form 483s
Every document, by year
- Form 483
2018: one Form 483; 2019: two Form 483s.
The story so far
Built from the dates and citations on the documents themselves.
- 2018–19Three Form 483s, at Torrance, California.
- 2019The longest 483 on file: 3 observations over 2 pages at Torrance, California.
Cited most
Across all Bachem Americas observations on file
- 21 CFR 211.188Batch production and control records2
- 21 CFR 211.192Production record review2
- 21 CFR 211.22Responsibilities of quality control unit2
- 21 CFR 211.160General requirements1
- 21 CFR 211.180General requirements1
The complete Bachem Americas file.
All 3 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
Torrance, California
Three Form 483s · 2018 to 2019 · 4 observations
Latest: Form 483, Dec 13, 2019 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-12-13 | 483 Form 483 | Torrance, California | 3 | $99 |
| 2019-06-12 | 483 Form 483 | Torrance, California | 1 | $99 |
| 2018-05-18 | 483 Form 483 | Torrance, California | — | $99 |
Investigators on these documents
FEI number 2024023 · most recent document Dec 13, 2019
About Bachem Americas, Inc.
How many FDA Form 483s has Bachem Americas, Inc. received?
FDA Intel has 3 Form 483s on file for Bachem Americas, Inc.; the most recent is dated Dec 13, 2019.
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 Dec 13, 2019, for the site in Torrance, 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 211.188 (Batch production and control records), 2 times; 21 CFR 211.192 (Production record review), 2 times; 21 CFR 211.22 (Responsibilities of quality control unit), 2 times.