FDA Inspection
Anew Optics, Inc.Anew Optics, Inc. – FDA Inspection, Jul 26, 2013
Record Details
This FDA Inspection record concerns Anew Optics, Inc., with an inspection on July 26, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Anew Optics, Inc.
- Inspection Date
- July 26, 2013
- Product Type
- Devices
View Company Profile
ID · 19eaa5d9-3c19-4a0b-b9f9-af6abab7ad67
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 841742
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
6- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(j)Design history file
- 21 CFR 820.20(b)Lack of or inadequate organizational structure
- 21 CFR 803.17Lack of Written MDR Procedures
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