FDA Inspection
GBS Commonwealth Co., Ltd.GBS Commonwealth Co., Ltd. – FDA Inspection, Feb 20, 2020
Record Details
This FDA Inspection record concerns GBS Commonwealth Co., Ltd., with an inspection on February 20, 2020, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- GBS Commonwealth Co., Ltd.
- Inspection Date
- February 20, 2020
- Product Type
- Devices
View Company Profile
ID · ba2d1517-6595-404e-9466-798b99917677
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1118348
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.25(b)Training records
- 21 CFR 820.50(a)(1)Evaluation and Selection, Suppliers, Contractors, etc.
- 21 CFR 820.70(i)Software validation for automated processes
- 21 CFR 820.30(j)Design history file
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