Company
United StatesSandstone Medical Technologies LLC, Birmingham, AL – FDA Inspections
Inspection records and compliance data for Sandstone Medical Technologies LLC in Birmingham, Alabama. 3 FDA inspections on record (1 OAI), last inspected May 30, 2012.
Company Profile
This profile covers Sandstone Medical Technologies LLC based in Birmingham, Alabama, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 1
- VAI
- 0
- NAI
- 2
- Form 483s
- 0
- Warning letters
- 0
First inspected May 26, 2009. Last inspected May 30, 2012.
Most cited issue areas
- Analysis of data/reports from data sources1 inspection
- DMR production process specifications1 inspection
- Lack of or inadequate DHR procedures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 30, 2012 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 783958 |
| April 12, 2010 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 657195 |
| May 26, 2009 | OAI | Medical Devices & Rad Health · Compliance: Devices | 585222 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Sandstone Medical Technologies LLC
FEI Number
3003991952
Address
102 Oxmoor Rd Ste 130, Birmingham, Alabama 35209, United States
Country
United States
ID: b0f65f45-b497-443f-bc5a-ade927d18c93