FDA Inspection
BioSculptor CorporationBioSculptor Corporation – FDA Inspection, Aug 16, 2011
Record Details
This FDA Inspection record concerns BioSculptor Corporation, with an inspection on August 16, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- BioSculptor Corporation
- Inspection Date
- August 16, 2011
- Product Type
- Devices
View Company Profile
ID · c15b66da-6e82-489b-a043-ae2d865abb5d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 739588
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 1040.10(h)(2)(ii)Reproductions of warnings
- 21 CFR 820.20(d)Quality plan
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation - Risk analysis
Full citation text and observation details available on the Dashboard.
Other FDA inspections of BioSculptor Corporation
7| Date | Classification | Office | Project area |
|---|---|---|---|
| October 19, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 13, 2020 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 20, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 30, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 30, 2010 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for BioSculptor Corporation
- FDA Inspection 1181701 - 2022-10-19
- FDA Inspection 1120660 - 2020-03-13
- FDA Inspection 945758 - 2015-10-20
- FDA Inspection 699615 - 2010-11-30
- FDA Inspection 699614 - 2010-11-30
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