FDA Inspection
PCASPCAS – FDA Inspection, Sep 7, 2018
Record Details
This FDA Inspection record concerns PCAS, with an inspection on September 7, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · b0b26fbe-9b08-4ac0-864b-91bcf9e3b838
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1064771
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
Other FDA inspections of PCAS
5| Date | Classification | Office | Project area |
|---|---|---|---|
| March 31, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 7, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 29, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 27, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 22, 2009 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for PCAS
- FDA Inspection 1289422 - 2022-03-31
- FDA Inspection 1124000 - 2019-03-07
- FDA Inspection 978336 - 2016-04-29
- FDA Inspection 838080 - 2013-06-27
- FDA Inspection 634763 - 2009-10-22
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