FDA Inspection
PolyPeptide Laboratories (Sweden) ABPolyPeptide Laboratories (Sweden) AB – FDA Inspection, Apr 10, 2019
Record Details
This FDA Inspection record concerns PolyPeptide Laboratories (Sweden) AB, with an inspection on April 10, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
- Person
- MRA McCulloughJ (Issuing Officer)
View Company Profile
ID · eeab8d89-54c5-40a9-94fa-6da2ed2e6810
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1096761
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
Other FDA inspections of PolyPeptide Laboratories (Sweden) AB
4| Date | Classification | Office | Project area |
|---|---|---|---|
| January 23, 2025 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 27, 2016 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 20, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 7, 2009 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for PolyPeptide Laboratories (Sweden) AB
- FDA Inspection 1273228 - 2025-01-23
- FDA Inspection 976058 - 2016-05-27
- FDA Inspection 854145 - 2013-09-20
- FDA Inspection 618582 - 2009-10-07
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