Oy Finnsusp Ab
Form 483 issued April 7, 2023 · Lieto, Finland
- Inspection
- Apr 3 – Apr 7, 2023
- Investigators
- Ig F. Ques· Petty Dennis Cantellops Paite
- Observations
- 6
- Pages
- 4
- FEI number
- 3014271245
In short: On April 7, 2023, FDA issued a Form 483 with 6 observations to Oy Finnsusp Ab in Lieto, Finland (FEI 3014271245) after an inspection that ran Apr 3 – Apr 7, 2023. The investigators were Ig F. Ques and Petty Dennis Cantellops Paite. Most observations concern production and materials; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Observations span 4 systems, led by production.
Most cited: 21 CFR 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
(Production…
- 02
(Material System) There was a failure to handle and store components at all times in a…
- 03
(Laboratory Control System) Written records of investigations into unexplained discrepancies do not always include…
- 04
(Laboratory Control System) Reserve samples from representative sample lots or batches of drug products selected by…
This inspection in context
Ig F. Ques
1 document · 2023
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Finland.
The firmOy Finnsusp Ab history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Oy Finnsusp Ab?
FDA listed 6 observations on this Form 483, mostly about production, materials and quality system. 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 Oy Finnsusp Ab?
Ig F. Ques and Petty Dennis Cantellops Paite are named on this Form 483, for the inspection of Apr 3 – Apr 7, 2023. Each investigator has a profile showing what they cite most.
When was Oy Finnsusp Ab inspected by FDA?
The inspection ran Apr 3 – Apr 7, 2023, and the Form 483 is dated April 7, 2023.
How do I get the full Form 483 for Oy Finnsusp Ab?
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.