FDA Inspection
Swiss Caps AGSwiss Caps AG – FDA Inspection, Jun 16, 2017
Record Details
This FDA Inspection record concerns Swiss Caps AG, with an inspection on June 16, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · f6dca497-03ec-453c-ace6-52e3ccdcf05e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1014881
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.68(b)Backup data not assured as exact and complete
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.192No written record of investigation
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Other FDA inspections of Swiss Caps AG
5| Date | Classification | Office | Project area |
|---|---|---|---|
| June 29, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 27, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 31, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 23, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 25, 2010 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Swiss Caps AG
- FDA Inspection 1258616 - 2023-06-29
- FDA Inspection 1109706 - 2019-09-27
- FDA Inspection 905387 - 2014-10-31
- FDA Inspection 811530 - 2012-11-23
- FDA Inspection 707937 - 2010-11-25
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