Oxford Biomedica (UK) Limited
Form 483 issued February 20, 2019 · Oxford, United Kingdom
- Inspection
- Feb 11 – Feb 20, 2019
- Investigator
- Prabhu P. Raju
- Observations
- 2
- Pages
- 4
- FEI number
- 3013199602
In short: On February 20, 2019, FDA issued a Form 483 with 2 observations to Oxford Biomedica (UK) Limited in Oxford, United Kingdom (FEI 3013199602) after an inspection that ran Feb 11 – Feb 20, 2019. The investigator was Prabhu P. Raju. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Observations span 1 system, led by quality system.
Most cited: 21 CFR 211.192 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The following unexplained discrepancies or the failure of °° (6) (4) .-” to meet specifications ‘were…
- 02
Observation 2: scanned text, readable in the full document.
This inspection in context
Prabhu P. Raju
21 documents · 2008–2023
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in France.
The firmOxford Biomedica (UK) Limited history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Oxford Biomedica (UK) Limited?
FDA listed 2 observations on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Oxford Biomedica (UK) Limited?
Prabhu P. Raju is named on this Form 483, for the inspection of Feb 11 – Feb 20, 2019. Each investigator has a profile showing what they cite most.
When was Oxford Biomedica (UK) Limited inspected by FDA?
The inspection ran Feb 11 – Feb 20, 2019, and the Form 483 is dated February 20, 2019.
How do I get the full Form 483 for Oxford Biomedica (UK) Limited?
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.