FDA Inspection
HTL-Strefa, Inc.HTL-Strefa, Inc. – FDA Inspection, Feb 21, 2013
Record Details
This FDA Inspection record concerns HTL-Strefa, Inc., with an inspection on February 21, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- HTL-Strefa, Inc.
- Inspection Date
- February 21, 2013
- Product Type
- Devices
View Company Profile
ID · bd3c046b-9521-41de-ad05-8305aabf407d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 821688
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.20(e)Quality System Procedures
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Other FDA inspections of HTL-Strefa, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 11, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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