FDA Inspection
New Leaf Medical IncNew Leaf Medical Inc – FDA Inspection, Sep 16, 2009
Record Details
This FDA Inspection record concerns New Leaf Medical Inc, with an inspection on September 16, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- New Leaf Medical Inc
- Inspection Date
- September 16, 2009
- Product Type
- Devices
View Company Profile
ID · 966271fc-c009-4b72-93a4-05cd3be2daa8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 611527
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 820.30(f)Design verification acceptance criteria
- 21 CFR 820.30(c)Design input - documentation
- 21 CFR 820.30(d)Acceptance criteria and essential outputs
- 21 CFR 820.30(c)Design input approval documentation
- 21 CFR 820.30(g)Design validation - documentation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of New Leaf Medical Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 1, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 17, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for New Leaf Medical Inc
- FDA Inspection 872439 - 2014-04-01
- FDA Inspection 700326 - 2010-11-17
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