Warning letter
Kaken Pharmaceuticals Co., Ltd.: warning letter of Jul 27, 2001
FDA warning letter UCM178278 · Center for Drug Evaluation and Research
Key facts
| Reference number | UCM178278 |
|---|---|
| Company | Kaken Pharmaceuticals Co., Ltd. |
| Subject | Active Pharmaceutical Ingredient/Adulterated |
| Issue date | Jul 27, 2001 |
| Posted date | Jul 27, 2001 |
| Issuing office | Center for Drug Evaluation and Research |
| Product type | Drugs |
| Country | 3 |
| Inspection city | Fujieda |
| Inspection start date | May 15, 2001 |
| Letter on fda.gov | web.archive.org |
At a glance
- 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: