FDA Inspection
Medicomp, Inc. dba ReactDXMedicomp, Inc. dba ReactDX – FDA Inspection, Jul 16, 2014
Record Details
This FDA Inspection record concerns Medicomp, Inc. dba ReactDX, with an inspection on July 16, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Medicomp, Inc. dba ReactDX
- Inspection Date
- July 16, 2014
- Product Type
- Devices
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ID · 8bdf43ee-88c7-4066-8145-f150a8c9370c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 887569
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation - Risk analysis
- 21 CFR 803.17(a)(3)Lack of System for Timely Submission of Reports
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Medicomp, Inc. dba ReactDX
3| Date | Classification | Office | Project area |
|---|---|---|---|
| August 30, 2023 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 20, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 11, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Medicomp, Inc. dba ReactDX
- FDA Inspection 1217172 - 2023-08-30
- FDA Inspection 1029758 - 2017-10-20
- FDA Inspection 739532 - 2011-08-11
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