FDA Inspection
Applied Medical Technology IncApplied Medical Technology Inc – FDA Inspection, Apr 3, 2012
Record Details
This FDA Inspection record concerns Applied Medical Technology Inc, with an inspection on April 3, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- April 3, 2012
- Product Type
- Devices
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ID · 3e83b13f-58b2-4b14-80d0-5e5c9401eef7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 773307
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
4- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
- 21 CFR 820.70(a)Production processes
- 21 CFR 803.17(a)(2)Lack of System for Determining MDR Events
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Other FDA inspections of Applied Medical Technology Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 9, 2018 | Not classified | Cincinnati District Office | |
| April 29, 2011 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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