FDA Inspection
MW Life Sciences - MansfieldMW Life Sciences - Mansfield – FDA Inspection, Jan 25, 2013
Record Details
This FDA Inspection record concerns MW Life Sciences - Mansfield, with an inspection on January 25, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- MW Life Sciences - Mansfield
- Inspection Date
- January 25, 2013
- Product Type
- Devices
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ID · 70c6ff0f-3eec-4999-a964-671769586db9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 817108
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.100(b)Documentation
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.120Lack of or inadequate procedures for labeling
- 21 CFR 820.40(b)Document change records, maintained.
- 21 CFR 820.90(b)(2)Product rework documentation, DHR {see also 820.184}
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Other FDA inspections of MW Life Sciences - Mansfield
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 17, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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