Valneva Scotland Ltd.
Form 483 issued April 24, 2018 · Livingston, United Kingdom
- Inspection
- Apr 16 – Apr 24, 2018
- Investigators
- Cynthia Jim· Dino Feigelstock· Gene Arey
- Observations
- 7
- Pages
- 6
- FEI number
- 3005315117
In short: On April 24, 2018, FDA issued a Form 483 with 7 observations to Valneva Scotland Ltd. in Livingston, United Kingdom (FEI 3005315117) after an inspection that ran Apr 16 – Apr 24, 2018. The investigators were Cynthia Jim, Dino Feigelstock and Gene Arey. Most observations concern quality system and laboratory controls; 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 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy and/or the failure of a batch…
- 02
Written records are not always made of investigations into unexplained discrepancies or the failure of a…
- 03
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 04
processing areas are deficient regarding…
This inspection in context
Cynthia Jim
20 documents · 2012–2024
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in North Carolina.
The firmValneva Scotland 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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Valneva Scotland Ltd.?
FDA listed 7 observations on this Form 483, mostly about quality system, laboratory controls 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 Valneva Scotland Ltd.?
Cynthia Jim, Dino Feigelstock and Gene Arey are named on this Form 483, for the inspection of Apr 16 – Apr 24, 2018. Each investigator has a profile showing what they cite most.
When was Valneva Scotland Ltd. inspected by FDA?
The inspection ran Apr 16 – Apr 24, 2018, and the Form 483 is dated April 24, 2018.
How do I get the full Form 483 for Valneva Scotland 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.