Fermion Oy
Form 483 issued March 17, 2023 · Hanko Pohjoinen, Finland
- Inspection
- Mar 13 – Mar 17, 2023
- Investigator
- David A. Oluwo
- Observations
- 1
- Pages
- 1
- FEI number
- 3002807817
In short: On March 17, 2023, FDA issued a Form 483 with 1 observation to Fermion Oy in Hanko Pohjoinen, Finland (FEI 3002807817) after an inspection that ran Mar 13 – Mar 17, 2023. The investigator was David A. Oluwo. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to thoroughly review any unexplained discrepancy whether or not the batch…
This inspection in context
David A. Oluwo
27 documents · 2017–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Maryland.
The firmFermion Oy 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 Fermion Oy?
FDA listed 1 observation on this Form 483, mostly about 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 Fermion Oy?
David A. Oluwo is named on this Form 483, for the inspection of Mar 13 – Mar 17, 2023. Each investigator has a profile showing what they cite most.
When was Fermion Oy inspected by FDA?
The inspection ran Mar 13 – Mar 17, 2023, and the Form 483 is dated March 17, 2023.
How do I get the full Form 483 for Fermion 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.