FDA Inspection
Control Solutions, LLC.Control Solutions, LLC. – FDA Inspection, Sep 15, 2022
Record Details
This FDA Inspection record concerns Control Solutions, LLC., with an inspection on September 15, 2022, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Control Solutions, LLC.
- Inspection Date
- September 15, 2022
- Product Type
- Devices
View Company Profile
ID · f57e4226-b6a0-46f3-8dcd-c695f3d32a8b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1179631
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.25(b)Training records
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.30(j)Design history file
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Control Solutions, LLC.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 20, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Control Solutions, LLC.
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.