FDA Inspection
HTL-Strefa, Inc.HTL-Strefa, Inc. – FDA Inspection, Feb 11, 2016
Record Details
This FDA Inspection record concerns HTL-Strefa, Inc., with an inspection on February 11, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- HTL-Strefa, Inc.
- Inspection Date
- February 11, 2016
- Product Type
- Devices
View Company Profile
ID · 287d64f7-0de4-4158-b52a-75f80c4285b7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 966079
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.72(a)Equipment control activity documentation
- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.22Quality Audits - defined intervals
- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 820.40(a)Document review, approval documentation
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Other FDA inspections of HTL-Strefa, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 21, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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