FDA Inspection
PENTAPHARM AGPENTAPHARM AG – FDA Inspection, Sep 15, 2016
Record Details
This FDA Inspection record concerns PENTAPHARM AG, with an inspection on September 15, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- PENTAPHARM AG
- Inspection Date
- September 15, 2016
- Product Type
- Devices
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ID · a6fc0494-430a-4e6d-be89-beab1b7af213
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 988595
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
1- 21 CFR 820.100(a)Lack of or inadequate procedures
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Other FDA inspections of PENTAPHARM AG
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 20, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for PENTAPHARM AG
- FDA Inspection 878383 - 2014-02-20
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