PCAS Finland Oy
Form 483 issued September 13, 2019 · TURKU, Finland
- Inspection
- Sep 13, 2019
- Investigator
- Nicholas L. Hunt
- Observations
- 3
- Pages
- 3
- FEI number
- 3003469991
In short: On September 13, 2019, FDA issued a Form 483 with 3 observations to PCAS Finland Oy in TURKU, Finland (FEI 3003469991) after an inspection that ran Sep 13, 2019. The investigator was Nicholas L. Hunt. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
3 of 3 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
(Cleaning procedures for dedicated and non-dedicated equipment…
- 02
Equipment qualifications did not always ensure production equipment…
- 03
Certification records for classified production areas where open processing…
This inspection in context
Nicholas L. Hunt
38 documents · 2017–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Arizona.
The firmPCAS Finland Oy history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at PCAS Finland Oy?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected PCAS Finland Oy?
Nicholas L. Hunt is named on this Form 483, for the inspection of Sep 13, 2019. Each investigator has a profile showing what they cite most.
When was PCAS Finland Oy inspected by FDA?
The inspection ran Sep 13, 2019, and the Form 483 is dated September 13, 2019.
How do I get the full Form 483 for PCAS Finland 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.