Company
United StatesSandare International, Inc - Inspection Records
Inspection records and compliance data for Sandare International, Inc in Cedar Hill, Texas. 2 FDA inspections on record, last inspected August 24, 2017.
Company Profile
This profile covers Sandare International, Inc based in Cedar Hill, Texas, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 2
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
First inspected May 31, 2013. Last inspected August 24, 2017.
Most cited issue areas
- Lack of or inadequate process validation1 inspection
- Lack of Written MDR Procedures1 inspection
- Purchasing controls, Lack of or inadequate procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 24, 2017 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1022963 |
| May 31, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 835304 |
FDA documents
Form 483s (1)
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Company Information
Name
Sandare International, Inc
FEI Number
1627187
Address
910 Kck Way, Cedar Hill, Texas 75104, United States
Country
United States
ID: 787d7727-1943-4854-9428-bfdfa61d1f90