FDA Inspection
Zeller Power Products, LLCZeller Power Products, LLC – FDA Inspection, Sep 24, 2021
Record Details
This FDA Inspection record concerns Zeller Power Products, LLC, with an inspection on September 24, 2021, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Zeller Power Products, LLC
- Inspection Date
- September 24, 2021
- Product Type
- Devices
View Company Profile
ID · c8d07333-2fd5-4f81-a19b-833c8784a48c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1152561
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
11- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.120Lack of or inadequate procedures for labeling
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.180Availability
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Other FDA inspections of Zeller Power Products, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 9, 2018 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| January 22, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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