FDA Inspection
Rochester Electro Medical, IncRochester Electro Medical, Inc – FDA Inspection, Feb 16, 2018
Record Details
This FDA Inspection record concerns Rochester Electro Medical, Inc, with an inspection on February 16, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · dbfefbe7-8258-440b-95a5-14aab9b58a84
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1042005
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
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Other FDA inspections of Rochester Electro Medical, Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 23, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 25, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Rochester Electro Medical, Inc
- FDA Inspection 887868 - 2014-07-23
- FDA Inspection 716839 - 2011-03-25
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