Company
United StatesNew Leaf Medical Inc, Cleveland, OH – FDA Inspections
Inspection records and compliance data for New Leaf Medical Inc in Cleveland, Ohio. 3 FDA inspections on record, last inspected April 01, 2014.
Company Profile
This profile covers New Leaf Medical Inc based in Cleveland, Ohio, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 2
- Form 483s
- 0
- Warning letters
- 0
First inspected September 16, 2009. Last inspected April 1, 2014.
Most cited issue areas
- Acceptance criteria and essential outputs1 inspection
- Design input approval documentation1 inspection
- Design input - documentation1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 1, 2014 | NAI | Medical Devices & Rad Health · Compliance: Devices | 872439 |
| November 17, 2010 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 700326 |
| September 16, 2009 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 611527 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
New Leaf Medical Inc
FEI Number
3007350668
Address
1768 E 25th St, Cleveland, Ohio 44114, United States
Country
United States
ID: 036cb8b3-a341-44e5-a816-5b818b60d665