FDA Inspection
Medstrat, Inc.Medstrat, Inc. – FDA Inspection, Sep 27, 2016
Record Details
This FDA Inspection record concerns Medstrat, Inc., with an inspection on September 27, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Medstrat, Inc.
- Inspection Date
- September 27, 2016
- Product Type
- Devices
View Company Profile
ID · cc9cac24-1077-425b-b175-f6b71971417d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 985581
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
6- 21 CFR 820.25(a)Personnel
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Medstrat, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| February 5, 2026 | NAI | Compliance: Devices | |
| March 10, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 9, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Medstrat, Inc.
- FDA Inspection 1304426 - 2026-02-05
- FDA Inspection 1164141 - 2022-03-10
- FDA Inspection 1071863 - 2018-11-09
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.