FDA Inspection
Bio Focus Co. Ltd.Bio Focus Co. Ltd. – FDA Inspection, Apr 17, 2013
Record Details
This FDA Inspection record concerns Bio Focus Co. Ltd., with an inspection on April 17, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Bio Focus Co. Ltd.
- Inspection Date
- April 17, 2013
- Product Type
- Devices
View Company Profile
ID · cc472d77-df12-47a6-9f13-2cd7f826d926
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 836155
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
8- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.80(c)Lack of or inadequate In-process acceptance procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.50(a)(2)Supplier oversight
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Bio Focus Co. Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 26, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Bio Focus Co. Ltd.
- FDA Inspection 918396 - 2015-02-26
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