FDA Inspection
Medstrat, Inc.Medstrat, Inc. – FDA Inspection, Nov 9, 2018
Record Details
This FDA Inspection record concerns Medstrat, Inc., with an inspection on November 9, 2018, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Shafiq Ahadi (Issuing Officer)
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ID · e4b22980-e10c-428d-a999-73d0f4b6f40f
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1071863
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.198(b)Review and evaluation for investigation
- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
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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 |
| September 27, 2016 | VAI | 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 985581 - 2016-09-27
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