FDA Inspection
Orthomerica Products, Inc.Orthomerica Products, Inc. – FDA Inspection, Sep 10, 2009
Record Details
This FDA Inspection record concerns Orthomerica Products, Inc., with an inspection on September 10, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Orthomerica Products, Inc.
- Inspection Date
- September 10, 2009
- Product Type
- Devices
View Company Profile
ID · 9c6c01af-0f85-4bd6-8c04-914e3c812546
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 611156
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.198(a)General
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
- 21 CFR 803.17(a)(2)Lack of System for Determining MDR Events
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Other FDA inspections of Orthomerica Products, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 26, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 7, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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