Evans Vaccines Limited
Form 483 issued June 10, 2003 · Speke, Liverpool, United Kingdom
- Inspection
- Jun 2 – Jun 10, 2003
- Investigators
- Jonathan McInnis· Omotunde O. Osunsanmi· Robert W. Jennings
- Observations
- 20
- Pages
- 7
- FEI number
- 3002806049
In short: On June 10, 2003, FDA issued a Form 483 with 20 observations to Evans Vaccines Limited in Speke, Liverpool, United Kingdom (FEI 3002806049) after an inspection that ran Jun 2 – Jun 10, 2003. The investigators were Jonathan McInnis, Omotunde O. Osunsanmi, Robert W. Jennings and Robin Levis. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and production account for 13 of 20 observations.
Most cited: 21 CFR 211.192 (6×) · 211.113 (6×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 02
Observation 2: scanned text, readable in the full document.
- 03
There is no documentation that the decisions to continue with the manufacturing of the Fluvirin monovalent…
- 04
Sterility failure investigations do not fully include all potential facts of contamination and…
This inspection in context
Jonathan McInnis
2 documents · 2003
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in United Kingdom.
The firmEvans Vaccines 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 Evans Vaccines Limited?
FDA listed 20 observations on this Form 483, mostly about quality system, production and biologics CGMP. 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 Evans Vaccines Limited?
Jonathan McInnis, Omotunde O. Osunsanmi, Robert W. Jennings and Robin Levis are named on this Form 483, for the inspection of Jun 2 – Jun 10, 2003. Each investigator has a profile showing what they cite most.
When was Evans Vaccines Limited inspected by FDA?
The inspection ran Jun 2 – Jun 10, 2003, and the Form 483 is dated June 10, 2003.
How do I get the full Form 483 for Evans Vaccines 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.