Warning letter
Fagron Group B.V.: warning letter of Jun 14, 2022
FDA warning letter 624255 · Division of Pharmaceutical Quality Operations III
Key facts
| Reference number | 624255 |
|---|---|
| Company | Fagron Group B.V. |
| Subject | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated |
| Issue date | Jun 14, 2022 |
| Posted date | Jun 28, 2022 |
| Issuing office | Division of Pharmaceutical Quality Operations III |
| Product type | Drugs |
| CFR sections cited | 11 |
| Inspection city | Saint Paul |
| Inspection ZIP | 55120 |
| Inspection start date | Nov 1, 2021 |
| 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: