FDA Inspection
Safe-Tec Clinical Products, LLCSafe-Tec Clinical Products, LLC – FDA Inspection, May 23, 2016
Record Details
This FDA Inspection record concerns Safe-Tec Clinical Products, LLC, with an inspection on May 23, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- May 23, 2016
- Product Type
- Devices
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ID · 280905cb-583e-4bc4-82c6-9bd14682e80a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 972439
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
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