FDA Inspection
Medical Devices, Inc.Medical Devices, Inc. – FDA Inspection, Apr 19, 2010
Record Details
This FDA Inspection record concerns Medical Devices, Inc., with an inspection on April 19, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Medical Devices, Inc.
- Inspection Date
- April 19, 2010
- Product Type
- Devices
View Company Profile
ID · da3ef2c8-24ac-4778-be08-afb66582e2de
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 658195
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.40(b)Document changes, review and approval, communication
- 21 CFR 820.198(a)General
- 21 CFR 820.80(b)Incoming inspection, testing, verification
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.120(b)DHR documentation of label release {see also 820.184}
- 21 CFR 820.20(b)(3)(i)Management representative implementing the quality system
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Other FDA inspections of Medical Devices, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 21, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Medical Devices, Inc.
- FDA Inspection 707255 - 2011-01-21
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