Warning letter
Rechargeable Power Energy North America LLC: warning letter of May 9, 2019
FDA warning letter 570911 · Division of Medical Device and Radiological Health Operations West (MDRHW)
Key facts
| Reference number | 570911 |
|---|---|
| Company | Rechargeable Power Energy North America 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 (MDRHW) |
| Product type | Devices |
| CFR sections cited | 803.17, 803, 820 |
| Inspection city | Las Vegas |
| Inspection ZIP | 89118 |
| Inspection start date | Nov 5, 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: