FDA Inspection
PF Soins de Sante SRIPF Soins de Sante SRI – FDA Inspection, Jun 7, 2019
Record Details
This FDA Inspection record concerns PF Soins de Sante SRI, with an inspection on June 7, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 94c721f9-797d-4967-9a09-47c21d7a5594
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1092301
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.22(a)Approve or reject components, products
- 21 CFR 211.192Investigations of discrepancies, failures
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Other FDA inspections of PF Soins de Sante SRI
5| Date | Classification | Office | Project area |
|---|---|---|---|
| October 27, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 4, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 7, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 28, 2011 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 20, 2009 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for PF Soins de Sante SRI
- FDA Inspection 1221283 - 2023-10-27
- FDA Inspection 995546 - 2016-11-04
- FDA Inspection 867494 - 2014-02-07
- FDA Inspection 734598 - 2011-06-28
- FDA Inspection 579469 - 2009-04-20
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