FDA Inspection
The Flexite CompanyThe Flexite Company – FDA Inspection, Oct 5, 2018
Record Details
This FDA Inspection record concerns The Flexite Company, with an inspection on October 5, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · b125821a-2411-437e-9560-233e332b70b7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1068392
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.198(a)Complaints
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 |
| November 19, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 9, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 19, 2011 | 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 951140 - 2015-11-19
- FDA Inspection 813877 - 2013-01-09
- FDA Inspection 706613 - 2011-01-19
- FDA Inspection 541724 - 2008-10-08
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