FDA Inspection
BL Optical Industry, Ltd.BL Optical Industry, Ltd. – FDA Inspection, Apr 5, 2012
Record Details
This FDA Inspection record concerns BL Optical Industry, Ltd., with an inspection on April 5, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- BL Optical Industry, Ltd.
- Inspection Date
- April 5, 2012
- Product Type
- Devices
View Company Profile
ID · c7a015df-546b-436e-b0c5-bb218e6cef71
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 781826
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.198(e)Records of complaint investigation
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