Warning letter
Kari Gran Inc.: warning letter of Nov 30, 2022
FDA warning letter 640035 · Division of Pharmaceutical Quality Operations IV
Key facts
| Reference number | 640035 |
|---|---|
| Company | Kari Gran Inc. |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Nov 30, 2022 |
| Posted date | Dec 6, 2022 |
| Issuing office | Division of Pharmaceutical Quality Operations IV |
| Product type | Drugs |
| CFR sections cited | 211.34, 211.100, 211.188, 211.84(d)(1), 211.166(a), 211.165(a), 211.22 |
| Inspection city | Seattle |
| Inspection ZIP | 98109 |
| Inspection start date | Jul 5, 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: