FDA Inspection
BBK Technology LLCBBK Technology LLC – FDA Inspection, May 11, 2012
Record Details
This FDA Inspection record concerns BBK Technology LLC, with an inspection on May 11, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- BBK Technology LLC
- Inspection Date
- May 11, 2012
- Product Type
- Devices
View Company Profile
ID · a6983095-1682-4d57-be91-7984adf03e6a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 780940
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 820.100(b)Documentation
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.20(b)Lack of or inadequate organizational structure
- 21 CFR 820.30(g)Design validation - documentation
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of BBK Technology LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 20, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for BBK Technology LLC
- FDA Inspection 1037961 - 2017-12-20
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