FDA Inspection
The Flexite CompanyThe Flexite Company – FDA Inspection, Jan 19, 2011
Record Details
This FDA Inspection record concerns The Flexite Company, with an inspection on January 19, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- The Flexite Company
- Inspection Date
- January 19, 2011
- Product Type
- Devices
View Company Profile
ID · 6c9fb47f-a0cd-4605-a9d3-d6586cc990a9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 706613
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
1- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of The Flexite Company
5| Date | Classification | Office | Project area |
|---|---|---|---|
| June 1, 2022 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 5, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 19, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 9, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 8, 2008 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for The Flexite Company
- FDA Inspection 1172026 - 2022-06-01
- FDA Inspection 1068392 - 2018-10-05
- FDA Inspection 951140 - 2015-11-19
- FDA Inspection 813877 - 2013-01-09
- FDA Inspection 541724 - 2008-10-08
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