Warning letter
Bioiberica, SAU: warning letter of Jun 30, 2022
FDA warning letter 629115 · Center for Drug Evaluation and Research | CDER
Key facts
| Reference number | 629115 |
|---|---|
| Company | Bioiberica, SAU |
| Subject | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated |
| Issue date | Jun 30, 2022 |
| Posted date | Jul 19, 2022 |
| Issuing office | Center for Drug Evaluation and Research | CDER |
| Product type | Drugs |
| Inspection city | Palafolls |
| Inspection start date | Jan 31, 2022 |
| 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: