FDA Inspection
Repro-Med Systems, Inc.Repro-Med Systems, Inc. – FDA Inspection, Oct 19, 2017
Record Details
This FDA Inspection record concerns Repro-Med Systems, Inc., with an inspection on October 19, 2017, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Li Li (Issuing Officer)
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ID · b794adc6-ca44-4acb-9efa-3ba57d3934bf
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1029627
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation - simulated testing
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Other FDA inspections of Repro-Med Systems, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| December 16, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 23, 2015 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| July 20, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 21, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 28, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Repro-Med Systems, Inc.
- FDA Inspection 996093 - 2016-12-16
- FDA Inspection 929452 - 2015-06-23
- FDA Inspection 793650 - 2012-07-20
- FDA Inspection 683171 - 2010-09-21
- FDA Inspection 627589 - 2009-10-28
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