Warning letter
Premier Trends LLC: warning letter of Mar 14, 2022
FDA warning letter 621313 · Division of Pharmaceutical Quality Operations I
Key facts
| Reference number | 621313 |
|---|---|
| Company | Premier Trends LLC |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Mar 14, 2022 |
| Posted date | Mar 22, 2022 |
| Issuing office | Division of Pharmaceutical Quality Operations I |
| Product type | Drugs |
| CFR sections cited | 211.68(a), 211.186(a), 211.84(d)(1), 207.17, 211.25(a), 211.165(a), 211.34, 211.22(a) |
| Inspection city | Monroe Twp |
| Inspection ZIP | 08831 |
| Inspection start date | Sep 23, 2021 |
| 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: