Warning letter
Zeller Power Products, LLC: warning letter of May 9, 2019
FDA warning letter 570909 · Division of Medical Device and Radiological Health Operations West
Key facts
| Reference number | 570909 |
|---|---|
| Company | Zeller Power Products, LLC |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | May 9, 2019 |
| Posted date | May 21, 2019 |
| Issuing office | Division of Medical Device and Radiological Health Operations West |
| Product type | Devices |
| CFR sections cited | 830, 801.3, 820, 801.20(a), 801, 830.300(a) |
| Inspection city | Wallace |
| Inspection ZIP | 83873 |
| Inspection start date | Nov 6, 2018 |
| Letter on fda.gov | fda.gov |
At a glance
- 1–9 CFR sections cited
- OAI Linked inspection classification
- Yes Form FDA 483 issued
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA warning letters
FDA warning letters notify a firm of significant regulatory violations found during an inspection or review and request prompt corrective action.
Source: U.S. Food and Drug Administration (FDA), Warning Letters · Source date: