FDA Inspection
Alcon Grieshaber AGAlcon Grieshaber AG – FDA Inspection, Apr 14, 2011
Record Details
This FDA Inspection record concerns Alcon Grieshaber AG, with an inspection on April 14, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Alcon Grieshaber AG
- Inspection Date
- April 14, 2011
- Product Type
- Devices
View Company Profile
ID · ff2542bf-2b9f-40a9-99d5-6090efa522b7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 722909
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
4- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
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Other FDA inspections of Alcon Grieshaber AG
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 19, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Alcon Grieshaber AG
- FDA Inspection 914434 - 2015-02-19
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