FDA Inspection
Andreas Hettich Gmbh & Co. KgAndreas Hettich Gmbh & Co. Kg – FDA Inspection, Jun 17, 2010
Record Details
This FDA Inspection record concerns Andreas Hettich Gmbh & Co. Kg, with an inspection on June 17, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- June 17, 2010
- Product Type
- Devices
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ID · e95f400f-3458-4d6d-ba90-ce018960656a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 670941
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
10- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.100(a)(1)Analysis of data sources
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.30(c)Design input - documentation
- 21 CFR 820.30(c)Design input procedures - addressing conflicting requirement
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.30(i)Design changes - validation vs. verification
- 21 CFR 820.72(b)(2)Calibration documentation
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Andreas Hettich Gmbh & Co. Kg
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 16, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Andreas Hettich Gmbh & Co. Kg
- FDA Inspection 874771 - 2014-04-16
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