FDA Inspection
Suncoast LaboratoriesSuncoast Laboratories – FDA Inspection, Dec 1, 2008
Record Details
This FDA Inspection record concerns Suncoast Laboratories, with an inspection on December 1, 2008, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Suncoast Laboratories
- Inspection Date
- December 1, 2008
- Product Type
- Devices
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ID · 8dbefe7c-77a2-4770-90f2-2a43aa0f2023
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 550873
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
15- 21 CFR 820.198(a)General
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.90(a)Specific non-conforming product procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 820.200(a)Servicing - Lack of or inadequate procedures
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Other FDA inspections of Suncoast Laboratories
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 3, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 5, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Suncoast Laboratories
- FDA Inspection 943805 - 2015-09-03
- FDA Inspection 648331 - 2010-02-05
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