FDA Inspection
Neo Vision Co LtdNeo Vision Co Ltd – FDA Inspection, May 12, 2016
Record Details
This FDA Inspection record concerns Neo Vision Co Ltd, with an inspection on May 12, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Neo Vision Co Ltd
- Inspection Date
- May 12, 2016
- Product Type
- Devices
View Company Profile
ID · e267f9d3-cc78-402d-8988-f0c9061fddef
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 972378
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.70(a)Production processes
- 21 CFR 803.17Lack of Written MDR Procedures
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