Evans Vaccines
Form 483 issued October 15, 2004 · Liverpool, United Kingdom
- Inspection
- Oct 10 – Oct 15, 2004
- Investigators
- David S. Cho· John D. Finkbohner· Mark A. Elengold
- Observations
- 14
- Pages
- 10
In short: On October 15, 2004, FDA issued a Form 483 with 14 observations to Evans Vaccines in Liverpool, United Kingdom after an inspection that ran Oct 10 – Oct 15, 2004. The investigators were David S. Cho, John D. Finkbohner, Mark A. Elengold, Omotunde O. Osunsanmi and Paula A. Trost. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Observations span 3 systems, led by quality system.
Most cited: 21 CFR 211.192 (3×) · 211.113 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Regarding Fluvirin Sterility Investigation #R/0198/10/04…
- 02
Regarding clean room design and operations for Formulation Room (Filtration) and…
- 03
Filtration occurs in Formulation Room and trivalent blending occurs in Formulation Room. Activities involve operators making…
- 04
Regarding Control of Bioburden…
This inspection in context
David S. Cho
1 document · 2004
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 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?
FDA listed 14 observations on this Form 483, mostly about quality system, facilities & equipment and production. 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?
David S. Cho, John D. Finkbohner, Mark A. Elengold, Omotunde O. Osunsanmi and Paula A. Trost are named on this Form 483, for the inspection of Oct 10 – Oct 15, 2004. Each investigator has a profile showing what they cite most.
When was Evans Vaccines inspected by FDA?
The inspection ran Oct 10 – Oct 15, 2004, and the Form 483 is dated October 15, 2004.
How do I get the full Form 483 for Evans Vaccines?
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.