FDA Inspection
BioSculptor CorporationBioSculptor Corporation – FDA Inspection, Nov 30, 2010
Record Details
This FDA Inspection record concerns BioSculptor Corporation, with an inspection on November 30, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- BioSculptor Corporation
- Inspection Date
- November 30, 2010
- Product Type
- Devices
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ID · 4cb7c48a-6fe8-4c87-baf0-90a10eebc08e
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 699614
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
10- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
- 21 CFR 820.198(e)Maintained
- 21 CFR 820.30(g)Design validation - Risk analysis
- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 1002.13Failure to submit
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 |
| August 16, 2011 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 30, 2010 | NAI | 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 739588 - 2011-08-16
- FDA Inspection 699615 - 2010-11-30
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