FinVector Oy
Form 483 issued May 28, 2024
- Inspection
- May 20 – May 28, 2024
- Investigators
- Gene D. Arcy· Lewis K. Antwi
- Observations
- 5
- Pages
- 5
- FEI number
- 3010227150
In short: On May 28, 2024, FDA issued a Form 483 with 5 observations to FinVector Oy (FEI 3010227150) after an inspection that ran May 20 – May 28, 2024. The investigators were Gene D. Arcy and Lewis K. Antwi. Most observations concern materials and quality system; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
Materials and quality system account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Establishment of the reliability of the container and closure supplier's report of analyses is deficient in…
- 02
The quality control unit lacks responsibility to approve all procedures or specifications impacting on the identity…
- 03
Written procedures for cleaning and maintenance fail to include…
- 04
Your firm has not adequately validated your adherent (b) (4) regarding cell infection in that certain…
This inspection in context
Gene D. Arcy
16 documents · 2003–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in California.
The firmFinVector Oy history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.84(d)(3)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at FinVector Oy?
FDA listed 5 observations on this Form 483, mostly about materials, quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures). The opening words of each observation are shown on this page.
Who inspected FinVector Oy?
Gene D. Arcy and Lewis K. Antwi are named on this Form 483, for the inspection of May 20 – May 28, 2024. Each investigator has a profile showing what they cite most.
When was FinVector Oy inspected by FDA?
The inspection ran May 20 – May 28, 2024, and the Form 483 is dated May 28, 2024.
How do I get the full Form 483 for FinVector Oy?
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.