Warning letter
New Era Naturals, LLC: warning letter of Jan 30, 2019
FDA warning letter 566658 · Los Angeles District Office
Key facts
| Reference number | 566658 |
|---|---|
| Company | New Era Naturals, LLC |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Jan 30, 2019 |
| Posted date | Mar 5, 2019 |
| Issuing office | Los Angeles District Office |
| Product type | Drugs |
| CFR sections cited | 207.17, 211.34, 211.22(a), 211.84(d)(1), 211.165(a), 211.186(a) |
| Inspection city | Durango |
| Inspection ZIP | 81303-7995 |
| Letter on fda.gov | fda.gov |
At a glance
- 1–9 CFR sections cited
- No 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: