FDA Inspection
Faulhaber Pinzetten KGFaulhaber Pinzetten KG – FDA Inspection, Jul 4, 2013
Record Details
This FDA Inspection record concerns Faulhaber Pinzetten KG, with an inspection on July 4, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Faulhaber Pinzetten KG
- Inspection Date
- July 4, 2013
- Product Type
- Devices
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ID · 4024584d-4958-4c69-825c-fa423445e5ef
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 839517
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
10- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.30(c)Design input - documentation
- 21 CFR 820.30(d)Design output - review and approval
- 21 CFR 820.30(b)Design plans - Lack of or inadequate
- 21 CFR 820.20(a)Management ensuring quality policy is understood
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.40(b)Change records, content
- 21 CFR 820.198(e)Records of complaint investigation
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Other FDA inspections of Faulhaber Pinzetten KG
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 26, 2024 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 28, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Faulhaber Pinzetten KG
- FDA Inspection 1253474 - 2024-09-26
- FDA Inspection 969508 - 2016-04-28
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