Aptuit (Oxford) Ltd.
FDA inspection history across 2 sites, 2016 to 2025
- 2
- Form 483s
Every document, by year
- Form 483
2016: one Form 483; 2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2016One Form 483, at Milton, United Kingdom.
- 2016The longest 483 on file: 7 observations over 6 pages at Milton, United Kingdom.
- 2025One Form 483, at Abingdon, United Kingdom.
Cited most
Across all Aptuit (Oxford) observations on file
- 21 CFR 211.113Control of microbiological contamination2
- 21 CFR 211.160General requirements2
- 21 CFR 211.192Production record review2
- 21 CFR 211.22Responsibilities of quality control unit2
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures2
The complete Aptuit (Oxford) 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
Abingdon, United Kingdom
One Form 483 · 2025 · 7 observations
Latest: Form 483, Aug 22, 2025 →Milton, United Kingdom
One Form 483 · 2016 · 7 observations
Latest: Form 483, Jul 22, 2016 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-08-22 | 483 Form 483 | Abingdon, United Kingdom | 7 | $99 |
| 2016-07-22 | 483 Form 483 | Milton, United Kingdom | 7 | $99 |
Investigators on these documents
FEI number 3003444315 · most recent document Aug 22, 2025
About Aptuit (Oxford) Ltd.
How many FDA Form 483s has Aptuit (Oxford) Ltd. received?
FDA Intel has 2 Form 483s on file for Aptuit (Oxford) Ltd.; the most recent is dated Aug 22, 2025.
When was Aptuit (Oxford) Ltd. last inspected by FDA?
The most recent FDA inspection document on file for Aptuit (Oxford) Ltd. is a Form 483 dated Aug 22, 2025, for the site in Abingdon, United Kingdom.
What did FDA cite at Aptuit (Oxford) Ltd.?
The regulations cited most in the observations on file for Aptuit (Oxford) Ltd. are 21 CFR 211.113 (Control of microbiological contamination), 2 times; 21 CFR 211.160 (General requirements), 2 times; 21 CFR 211.192 (Production record review), 2 times.