FDA Inspection
St. Shine Optical Co., Ltd.St. Shine Optical Co., Ltd. – FDA Inspection, May 23, 2013
Record Details
This FDA Inspection record concerns St. Shine Optical Co., Ltd., with an inspection on May 23, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- St. Shine Optical Co., Ltd.
- Inspection Date
- May 23, 2013
- Product Type
- Devices
View Company Profile
ID · e478e1e1-1ab7-41e1-9be7-3912dc21eaad
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 836130
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.30(f)Design verification procedures
- 21 CFR 820.70(a)Process control procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
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