FDA Inspection
UniStrip Technologies, LLCUniStrip Technologies, LLC – FDA Inspection, Aug 19, 2015
Record Details
This FDA Inspection record concerns UniStrip Technologies, LLC, with an inspection on August 19, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- UniStrip Technologies, LLC
- Inspection Date
- August 19, 2015
- Product Type
- Devices
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ID · dc030d15-28d8-4a0a-abec-ec9ff1d32a16
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 940208
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
11- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.25(b)Training records
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.160(a)Lack of or inadequate procedures for distribution
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.20(b)Lack of or inadequate organizational structure
Showing 10 of 11 citations.
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Other FDA inspections of UniStrip Technologies, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 1, 2019 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for UniStrip Technologies, LLC
- FDA Inspection 1098811 - 2019-05-01
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