Owen Biosciences Inc.
FDA inspection history in Baton Rouge, Louisiana, 2020 to 2025
- 2
- Form 483s
- 1
- Warning letter
Every document, by year
- Warning letter
- Form 483
2020: one Form 483; 2025: one warning letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2020One Form 483, at Baton Rouge, Louisiana.
- 2020The longest 483 on file: 9 observations over 6 pages at Baton Rouge, Louisiana.
- 2025One warning letter and one Form 483, at Baton Rouge, Louisiana.
Cited most
Across all Owen Biosciences observations on file
- 21 CFR 211.25(a)Personnel qualifications3
- 21 CFR 211.188(a)Batch production and control records2
- 21 CFR 211.101(c)Charge-in of components1
- 21 CFR 211.105(a)Equipment identification1
- 21 CFR 211.137(a)Expiration dating1
The complete Owen Biosciences 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
Baton Rouge, Louisiana
Two Form 483s and one warning letter · 2020 to 2025 · 15 observations
Latest: Warning letter, Oct 30, 2025 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-10-30 | Warning letter Warning letter | Baton Rouge, Louisiana | — | $99 |
| 2025-03-27 | 483 Form 483 | Baton Rouge, Louisiana | 6 | $99 |
| 2020-02-14 | 483 Form 483 | Baton Rouge, Louisiana | 9 | $99 |
Investigators on these documents
FEI number 1000132299 · most recent document Oct 30, 2025
About Owen Biosciences Inc.
How many FDA Form 483s has Owen Biosciences Inc. received?
FDA Intel has 2 Form 483s on file for Owen Biosciences Inc.; the most recent is dated Mar 27, 2025.
When was Owen Biosciences Inc. last inspected by FDA?
The most recent FDA inspection document on file for Owen Biosciences Inc. is a Form 483 dated Mar 27, 2025, for the site in Baton Rouge, Louisiana.
What did FDA cite at Owen Biosciences Inc.?
The regulations cited most in the observations on file for Owen Biosciences Inc. are 21 CFR 211.25(a) (Personnel qualifications), 3 times; 21 CFR 211.188(a) (Batch production and control records), 2 times; 21 CFR 211.101(c) (Charge-in of components), 1 time.
Has Owen Biosciences Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Owen Biosciences Inc.; the most recent is dated Oct 30, 2025.