FDA Inspection
Ulrich Gmbh & Co. KGFDA Inspection 833997 - Ulrich Gmbh & Co. KG - May 03, 2013
Record Details
This FDA Inspection record concerns Ulrich Gmbh & Co. KG, with an inspection on May 3, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Ulrich Gmbh & Co. KG
- Inspection Date
- May 3, 2013
- Product Type
- Devices
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ID · a18175aa-f158-4050-8099-b79c37f8c475
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 833997
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.30(g)Design validation acceptance criteria
- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation - Risk analysis
- 21 CFR 820.30(e)Design review - documentation
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Ulrich Gmbh & Co. KG
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 10, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 10, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Ulrich Gmbh & Co. KG
- FDA Inspection 888754 - 2014-07-10
- FDA Inspection 667946 - 2010-06-10
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