Warning letter
Kyowa Hakko Bio Co., Ltd.: warning letter of Aug 10, 2018
FDA warning letter 543924 · Center for Drug Evaluation and Research
Key facts
| Reference number | 543924 |
|---|---|
| Company | Kyowa Hakko Bio Co., Ltd. |
| Subject | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated |
| Issue date | Aug 10, 2018 |
| Posted date | Aug 21, 2018 |
| Issuing office | Center for Drug Evaluation and Research |
| Product type | Drugs |
| Inspection city | Hofu |
| Inspection start date | Sep 4, 2017 |
| Letter on fda.gov | fda.gov |
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: