Warning letter
Fenwal International, Inc.: warning letter of Jun 14, 2020
FDA warning letter 603610 · Division of Biological Products Operations I
Key facts
| Reference number | 603610 |
|---|---|
| Company | Fenwal International, Inc. |
| Subject | CGMP Deviations |
| Issue date | Jun 14, 2020 |
| Posted date | Jun 16, 2020 |
| Issuing office | Division of Biological Products Operations I |
| Product type | Biologics |
| Inspection city | Maricao |
| Inspection ZIP | 00606 |
| Inspection start date | Sep 16, 2019 |
| 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: