FDA Inspection
Central Surgical Co. Ltd.Central Surgical Co. Ltd. – FDA Inspection, Aug 14, 2012
Record Details
This FDA Inspection record concerns Central Surgical Co. Ltd., with an inspection on August 14, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Central Surgical Co. Ltd.
- Inspection Date
- August 14, 2012
- Product Type
- Devices
View Company Profile
ID · 1662df92-7e47-4891-87c6-e91cf02d27dd
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 797321
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.70(a)Production processes
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