Company
United StatesBioSculptor Corporation, Hialeah, FL – FDA Inspections
Inspection records and compliance data for BioSculptor Corporation in Hialeah, Florida. 8 FDA inspections on record (1 OAI), last inspected October 19, 2022.
Company Profile
This profile covers BioSculptor Corporation based in Hialeah, Florida, United States.
FDA Inspection History
- FDA inspections
- 8
- OAI
- 1
- VAI
- 4
- NAI
- 3
- Form 483s
- 0
- Warning letters
- 0
First inspected February 3, 2009. Last inspected October 19, 2022.
Most cited issue areas
- Design validation - Risk analysis2 inspections
- Management review - Lack of or inadequate procedures2 inspections
- Acceptable supplier records, inadequate records1 inspection
FDA inspections (8)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 19, 2022 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1181701 |
| March 13, 2020 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1120660 |
| October 20, 2015 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 945758 |
| August 16, 2011 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 739588 |
| November 30, 2010 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 699615 |
| November 30, 2010 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 699614 |
| February 3, 2009 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 562804 |
| February 3, 2009 | VAI | Medical Devices & Rad Health · Compliance: Devices | 561550 |
FDA documents
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Company Information
Name
BioSculptor Corporation
FEI Number
1000560772
Address
2480 W 82nd St Unit 1, Hialeah, Florida 33016, United States
Country
United States
ID: f6ac4ae6-7658-4011-b39e-b2241b1e58aa