Warning letter
Drivergent, Inc.: warning letter of May 1, 2023
FDA warning letter 647234 · Division of Pharmaceutical Quality Operations III
Key facts
| Reference number | 647234 |
|---|---|
| Company | Drivergent, Inc. |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | May 1, 2023 |
| Posted date | May 9, 2023 |
| Issuing office | Division of Pharmaceutical Quality Operations III |
| Product type | Drugs |
| CFR sections cited | 201.128, 211.34, 211.58, 211.165, 211.182, 211.188, 211.192, 211.198, 330, 207.77(a), 211.22(a), 211.84(d)(1) and 5 more |
| Inspection city | Fraser |
| Inspection ZIP | 48026 |
| Inspection start date | Oct 31, 2022 |
| Letter on fda.gov | fda.gov |
At a glance
- 10–99 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: