FDA Inspection
The Flexite CompanyThe Flexite Company – FDA Inspection, Nov 19, 2015
Record Details
This FDA Inspection record concerns The Flexite Company, with an inspection on November 19, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- The Flexite Company
- Inspection Date
- November 19, 2015
- Product Type
- Devices
View Company Profile
ID · 4ed0a874-d47d-4c31-8e96-12e72c73bbed
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 951140
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.60Identification procedures, Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product control
- 21 CFR 820.40(b)Document change records, maintained.
- 21 CFR 820.40(a)Document review, approval documentation
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 |
| 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 1068392 - 2018-10-05
- FDA Inspection 813877 - 2013-01-09
- FDA Inspection 706613 - 2011-01-19
- FDA Inspection 541724 - 2008-10-08
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