FDA Inspection
Biopsy Sciences, LLCBiopsy Sciences, LLC – FDA Inspection, Sep 15, 2011
Record Details
This FDA Inspection record concerns Biopsy Sciences, LLC, with an inspection on September 15, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Biopsy Sciences, LLC
- Inspection Date
- September 15, 2011
- Product Type
- Devices
View Company Profile
ID · cd27ca57-7e8d-4da6-8104-38855213229e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 745413
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
8- 21 CFR 820.30(b)Design plans - Lack of or inadequate
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.198(e)Records of complaint investigation
- 21 CFR 820.30(j)Design history file
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Biopsy Sciences, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 15, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Biopsy Sciences, LLC
- FDA Inspection 895226 - 2014-09-15
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