Valneva Scotland Ltd.
Form 483 issued September 9, 2022 · Livingston
- Inspection
- Sep 1 – Sep 9, 2022
- Investigators
- Eileen A. Liu· Eileen A. Ltu
- Observations
- 10
- Pages
- 7
- FEI number
- 3005315117
In short: On September 9, 2022, FDA issued a Form 483 with 10 observations to Valneva Scotland Ltd. in Livingston (FEI 3005315117) after an inspection that ran Sep 1 – Sep 9, 2022. The investigators were Eileen A. Liu and Eileen A. Ltu. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Quality system and facilities & equipment account for 7 of 10 observations.
Most cited: 21 CFR 211.42 (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 and procedures applicable to the quality control unit…
- 02
There is a failure to thoroughly review any unexplained discrepancy to meet any of its specifications…
- 03
Written procedures are not established or followed for evaluations done at least (b) (4) and including…
- 04
Biological Product Deviation Reporting (BPDR) were not reported within…
This inspection in context
Eileen A. Liu
41 documents · 2014–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
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 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Valneva Scotland Ltd.?
FDA listed 10 observations on this Form 483, mostly about quality system, facilities & equipment and biologics CGMP. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Valneva Scotland Ltd.?
Eileen A. Liu and Eileen A. Ltu are named on this Form 483, for the inspection of Sep 1 – Sep 9, 2022. Each investigator has a profile showing what they cite most.
When was Valneva Scotland Ltd. inspected by FDA?
The inspection ran Sep 1 – Sep 9, 2022, and the Form 483 is dated September 9, 2022.
How do I get the full Form 483 for Valneva Scotland Ltd.?
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