Warning letter
NuGeneration Technologies LLC: warning letter of Mar 13, 2023
FDA warning letter 645821 · Division of Pharmaceutical Quality Operations IV
Key facts
| Reference number | 645821 |
|---|---|
| Company | NuGeneration Technologies LLC |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Mar 13, 2023 |
| Posted date | Mar 28, 2023 |
| Issuing office | Division of Pharmaceutical Quality Operations IV |
| Product type | Drugs |
| CFR sections cited | 211.84(d)(1), 211.100(a), 211.165(a), 211.34, 211.166(a) |
| Inspection city | Emeryville |
| Inspection ZIP | 94608 |
| Inspection start date | Sep 14, 2022 |
| 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: