FDA Inspection
HTE Investment Group, LLC dba MD DermisHTE Investment Group, LLC dba MD Dermis – FDA Inspection, Feb 2, 2018
Record Details
This FDA Inspection record concerns HTE Investment Group, LLC dba MD Dermis, with an inspection on February 2, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 6741b0bd-83b9-4ffe-af90-50b8220fd5bc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1039505
- FDA center
- Medical Devices & Rad Health
- Project area
- Radiation Control and Health Safety Act
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.200(a)Servicing - Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of HTE Investment Group, LLC dba MD Dermis
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 18, 2019 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for HTE Investment Group, LLC dba MD Dermis
- FDA Inspection 1106126 - 2019-07-18
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