FDA Inspection
Medicomp, Inc. dba ReactDXMedicomp, Inc. dba ReactDX – FDA Inspection, Oct 20, 2017
Record Details
This FDA Inspection record concerns Medicomp, Inc. dba ReactDX, with an inspection on October 20, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 74d3c7da-8d99-45c2-b6ec-261c9bce859c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1029758
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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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 |
| July 16, 2014 | 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 887569 - 2014-07-16
- FDA Inspection 739532 - 2011-08-11
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