FDA Inspection
Repro-Med Systems, Inc.Repro-Med Systems, Inc. – FDA Inspection, Jun 23, 2015
Record Details
This FDA Inspection record concerns Repro-Med Systems, Inc., with an inspection on June 23, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Repro-Med Systems, Inc.
- Inspection Date
- June 23, 2015
- Product Type
- Devices
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ID · f30e24d8-0d40-417a-8e4c-2fdfc24950db
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 929452
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
15- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.30(b)Design plans - Lack of or inadequate
- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.160(a)Lack of or inadequate procedures for distribution
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(h)Design transfer - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
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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 |
| December 16, 2016 | NAI | 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 996093 - 2016-12-16
- FDA Inspection 793650 - 2012-07-20
- FDA Inspection 683171 - 2010-09-21
- FDA Inspection 627589 - 2009-10-28
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