Natren Inc.
FDA inspection history in Westlake Village, California, 2019 to 2023
- 2
- Form 483s
Every document, by year
- Form 483
2019: one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019One Form 483, at Westlake Village, California.
- 2023One Form 483, at Westlake Village, California.
- 2023The longest 483 on file: 3 observations over 4 pages at Westlake Village, California.
Cited most
Across all Natren observations on file
- 21 CFR 211.100(b)Written procedures; deviations1
- 21 CFR 211.160(a)General requirements1
- 21 CFR 211.166(c)(1)Stability testing1
- 21 CFR 211.22(a)Responsibilities of quality control unit1
- 21 CFR 211.84(a)Testing and approval or rejection of components, drug product containers, and closures1
The complete Natren 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
Westlake Village, California
Two Form 483s · 2019 to 2023 · 5 observations
Latest: Form 483, Nov 2, 2023 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-11-02 | 483 Form 483 | Westlake Village, California | 3 | $99 |
| 2019-10-08 | 483 Form 483 | Westlake Village, California | 2 | $99 |
Investigators on these documents
FEI number 2024261 · most recent document Nov 2, 2023
About Natren Inc.
How many FDA Form 483s has Natren Inc. received?
FDA Intel has 2 Form 483s on file for Natren Inc.; the most recent is dated Nov 2, 2023.
When was Natren Inc. last inspected by FDA?
The most recent FDA inspection document on file for Natren Inc. is a Form 483 dated Nov 2, 2023, for the site in Westlake Village, California.
What did FDA cite at Natren Inc.?
The regulations cited most in the observations on file for Natren Inc. are 21 CFR 211.100(b) (Written procedures; deviations), 1 time; 21 CFR 211.160(a) (General requirements), 1 time; 21 CFR 211.166(c)(1) (Stability testing), 1 time.