Westwood Laboratories, LLC
FDA inspection history in Azusa, California, 2019 to 2024
- 5
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2019: two Form 483s; 2022: one Form 483; 2023: one Form 483; 2024: one Form 483 and one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2019Two Form 483s, at Azusa, California.
- 2022–24Three Form 483s and one warning letter, at Azusa, California.
- 2023The longest 483 on file: 7 observations over 7 pages at Azusa, California.
Cited most
Across all Westwood Laboratories observations on file
- 21 CFR 211.68(b)Automatic, mechanical, and electronic equipment3
- 21 CFR 211.84(d)(1)Testing and approval or rejection of components, drug product containers, and closures3
- 21 CFR 211.100(a)Written procedures; deviations2
- 21 CFR 211.113(a)Control of microbiological contamination2
- 21 CFR 211.160(a)General requirements2
The complete Westwood Laboratories file.
All 6 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
Azusa, California
Five Form 483s and one warning letter · 2019 to 2024 · 25 observations
Latest: Form 483, Oct 31, 2024 →
Documents
6 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-10-31 | 483 Form 483 | Azusa, California | 6 | $99 |
| 2024-04-17 | Warning letter Warning letter | Azusa, California | — | $99 |
| 2023-11-20 | 483 Form 483 | Azusa, California | 7 | $99 |
| 2022-04-05 | 483 Form 483 | Azusa, California | 4 | $99 |
| 2019-08-02 | 483 Form 483 | Azusa, California | 5 | $99 |
| 2019-05-30 | 483 Form 483 | Azusa, California | 3 | $99 |
Investigators on these documents
Alan L. Truong (1)Carolina D. Vasquez (1)Esteban Beltran (1)Gloria E. Andia (1)Stephon D. Tillis (1)
FEI number 2020372 · most recent document Oct 31, 2024
About Westwood Laboratories, LLC
How many FDA Form 483s has Westwood Laboratories, LLC received?
FDA Intel has 5 Form 483s on file for Westwood Laboratories, LLC; the most recent is dated Oct 31, 2024.
When was Westwood Laboratories, LLC last inspected by FDA?
The most recent FDA inspection document on file for Westwood Laboratories, LLC is a Form 483 dated Oct 31, 2024, for the site in Azusa, California.
What did FDA cite at Westwood Laboratories, LLC?
The regulations cited most in the observations on file for Westwood Laboratories, LLC are 21 CFR 211.68(b) (Automatic, mechanical, and electronic equipment), 3 times; 21 CFR 211.84(d)(1) (Testing and approval or rejection of components, drug product containers, and closures), 3 times; 21 CFR 211.100(a) (Written procedures; deviations), 2 times.
Has Westwood Laboratories, LLC received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Westwood Laboratories, LLC; the most recent is dated Apr 17, 2024.