Company
United StatesHTL-Strefa, Inc., Woodstock, GA – FDA Inspections
Inspection records and compliance data for HTL-Strefa, Inc. in Woodstock, Georgia. 2 FDA inspections on record, last inspected February 11, 2016.
Company Profile
This profile covers HTL-Strefa, Inc. based in Woodstock, Georgia, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 2
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
First inspected February 21, 2013. Last inspected February 11, 2016.
Most cited issue areas
- Management review - Lack of or inadequate procedures2 inspections
- Quality System Procedures2 inspections
- Calibration, Inspection, etc. Procedures Lack of or Inadequ1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 11, 2016 | VAI | Medical Devices & Rad Health · Compliance: Devices | 966079 |
| February 21, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 821688 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
HTL-Strefa, Inc.
FEI Number
3006142663
Address
113 Towne Lake Pkwy Ste 120, Woodstock, Georgia 30188, United States
Country
United States
ID: 01f3c516-4993-40fb-8704-65f4a69ef4df