FDA Inspection
PCAS Finland OyPCAS Finland Oy – FDA Inspection, Sep 13, 2019
Record Details
This FDA Inspection record concerns PCAS Finland Oy, with an inspection on September 13, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 09fc2aca-8abd-4977-98bf-3a9d933b4705
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1103407
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
Other FDA inspections of PCAS Finland Oy
7| Date | Classification | Office | Project area |
|---|---|---|---|
| June 7, 2024 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| January 10, 2024 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 15, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 15, 2015 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 8, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for PCAS Finland Oy
- FDA Inspection 1242545 - 2024-06-07
- FDA Inspection 1274168 - 2024-01-10
- FDA Inspection 1029624 - 2017-09-15
- FDA Inspection 928927 - 2015-05-15
- FDA Inspection 820512 - 2013-02-08
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