FDA Inspection
Zeller Power Products, LLCZeller Power Products, LLC – FDA Inspection, Jan 22, 2016
Record Details
This FDA Inspection record concerns Zeller Power Products, LLC, with an inspection on January 22, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Zeller Power Products, LLC
- Inspection Date
- January 22, 2016
- Product Type
- Devices
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ID · fd4561fe-b976-4cc6-8544-ffd766f667da
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 960780
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 820.30(g)Design validation - production units
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Zeller Power Products, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 24, 2021 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 9, 2018 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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