FDA Inspection
Suez Treatment Solutions, Inc.Suez Treatment Solutions, Inc. – FDA Inspection, Feb 26, 2009
Record Details
This FDA Inspection record concerns Suez Treatment Solutions, Inc., with an inspection on February 26, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- February 26, 2009
- Product Type
- Devices
View Company Profile
ID · d25ecda2-1307-43ea-92ee-b8984da18292
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 564983
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
17- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.30(d)Design output - documentation
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.20(b)(3)Management representative
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.30(d)Design output procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification procedures
Showing 10 of 17 citations.
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Suez Treatment Solutions, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| October 17, 2025 | NAI | Dallas District Office | Postmarket Assurance: Medical Devices |
| September 16, 2022 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 16, 2018 | Not classified | Dallas District Office | |
| December 18, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Suez Treatment Solutions, Inc.
- FDA Inspection 1287372 - 2025-10-17
- FDA Inspection 1179733 - 2022-09-16
- FDA Inspection 1066146 - 2018-08-16
- FDA Inspection 635451 - 2009-12-18
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.