FDA Inspection
Innovamed Health LLCInnovamed Health LLC – FDA Inspection, Jun 26, 2009
Record Details
This FDA Inspection record concerns Innovamed Health LLC, with an inspection on June 26, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Innovamed Health LLC
- Inspection Date
- June 26, 2009
- Product Type
- Devices
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ID · ec2561eb-e2ca-405e-978e-4a60715ed040
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 593121
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.198(a)General
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.181(a)DMR device specifications
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Innovamed Health LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 6, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Innovamed Health LLC
- FDA Inspection 864999 - 2014-02-06
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