Aptuit (Oxford) Ltd.
Form 483 issued August 22, 2025 · Abingdon, United Kingdom
- Inspection
- Aug 22, 2025
- Investigator
- Jose M. Cayuela
- Observations
- 7
- Pages
- 4
- FEI number
- 3003444315
In short: On August 22, 2025, FDA issued a Form 483 with 7 observations to Aptuit (Oxford) Ltd. in Abingdon, United Kingdom (FEI 3003444315) after an inspection that ran Aug 22, 2025. The investigator was Jose M. Cayuela. Most observations concern quality system and materials; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Quality system and materials account for 5 of 7 observations.
Most cited: 21 CFR 211.22 (2×) · 211.84 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities applicable to the quality unit…
- 02
There is a failure to thoroughly review any unexplained discrepancy and the failure to of a…
- 03
Procedures designed to prevent microbiological contamination of products purporting to be…
- 04
The quality system to approve contract laboratories to perform microbiological testing of ^^ APIs…
This inspection in context
Jose M. Cayuela
23 documents · 2012–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmAptuit (Oxford) Ltd. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Aptuit (Oxford) Ltd.?
FDA listed 7 observations on this Form 483, mostly about quality system, materials and production. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Aptuit (Oxford) Ltd.?
Jose M. Cayuela is named on this Form 483, for the inspection of Aug 22, 2025. Each investigator has a profile showing what they cite most.
When was Aptuit (Oxford) Ltd. inspected by FDA?
The inspection ran Aug 22, 2025, and the Form 483 is dated August 22, 2025.
How do I get the full Form 483 for Aptuit (Oxford) Ltd.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.