FDA Inspection
Zenni Optical, Inc.Zenni Optical, Inc. – FDA Inspection, Jan 29, 2009
Record Details
This FDA Inspection record concerns Zenni Optical, Inc., with an inspection on January 29, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Zenni Optical, Inc.
- Inspection Date
- January 29, 2009
- Product Type
- Devices
View Company Profile
ID · ab916c95-9b39-4fdc-ae12-eb17e2b22cb4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 554744
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
11- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.20Management responsibility
- 21 CFR 820.20(a)Management ensuring quality policy is understood
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.160(a)Control/distribution procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.180Availability
- 21 CFR 820.100(a)Lack of or inadequate procedures
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Other FDA inspections of Zenni Optical, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 15, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
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