FDA Inspection
Flotec, Inc.Flotec, Inc. – FDA Inspection, Sep 1, 2016
Record Details
This FDA Inspection record concerns Flotec, Inc., with an inspection on September 1, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Flotec, Inc.
- Inspection Date
- September 1, 2016
- Product Type
- Devices
View Company Profile
ID · c2a15cfa-6a3a-471c-8ab8-2cc24d4e36d9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 986224
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
4- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Flotec, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| August 8, 2019 | Not classified | Detroit District Office | |
| May 9, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 21, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Flotec, Inc.
- FDA Inspection 1132345 - 2019-08-08
- FDA Inspection 830970 - 2013-05-09
- FDA Inspection 745695 - 2011-09-21
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