FDA Inspection
Repro-Med Systems, Inc.Repro-Med Systems, Inc. – FDA Inspection, Dec 16, 2016
Record Details
This FDA Inspection record concerns Repro-Med Systems, Inc., with an inspection on December 16, 2016, issued by the Center for Devices and Radiological Health, covering devices.
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ID · ca0b7afe-57e2-43ac-8005-9591400d9a99
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 996093
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 806.10(a)(1)Report of risk to health
- 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(f)Design verification - output does not meet input requirement
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.90(b)(2)Product rework documentation, DHR {see also 820.184}
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Other FDA inspections of Repro-Med Systems, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| October 19, 2017 | 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 1029627 - 2017-10-19
- 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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