FDA Inspection
Medical Equipment Device SpecialistsMedical Equipment Device Specialists – FDA Inspection, Oct 16, 2009
Record Details
This FDA Inspection record concerns Medical Equipment Device Specialists, with an inspection on October 16, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- October 16, 2009
- Product Type
- Devices
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ID · 5e726d86-df64-4e65-bbe0-2c1eb9f5a9e0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 628201
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
10- 21 CFR 820.80(e)Documentation
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.198(a)General
- 21 CFR 820.198(a)(3)Processing MDRs {see also 803, 804}
- 21 CFR 820.40(a)Document review, approval by designated individual
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.30(j)Design history file
- 21 CFR 820.100(a)(3)Identifying corrective & preventive actions
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Other FDA inspections of Medical Equipment Device Specialists
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 6, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Medical Equipment Device Specialists
- FDA Inspection 890741 - 2014-08-06
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