FDA Inspection
Zeller Power Products, LLCZeller Power Products, LLC – FDA Inspection, Nov 9, 2018
Record Details
This FDA Inspection record concerns Zeller Power Products, LLC, with an inspection on November 9, 2018, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · e62b6b72-b671-4183-ab38-771ae2107f12
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1071492
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
- Enforcement
- Warning Letter
FDA Citations
11- 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(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate 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 820.30(g)Design validation - production units
Showing 10 of 11 citations.
Full citation text and observation details available on the Dashboard.
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 |
| January 22, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Zeller Power Products, LLC
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.