Warning letter
Cangene BioPharma, LLC dba Emergent BioSolutions: warning letter of Aug 10, 2022
FDA warning letter 630316 · Division of Pharmaceutical Quality Operations I
Key facts
| Reference number | 630316 |
|---|---|
| Company | Cangene BioPharma, LLC dba Emergent BioSolutions |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Aug 10, 2022 |
| Posted date | Aug 16, 2022 |
| Issuing office | Division of Pharmaceutical Quality Operations I |
| Product type | Drugs |
| CFR sections cited | 211.34, 211.67(a), 211.113(b) |
| Inspection city | Baltimore |
| Inspection ZIP | 21230 |
| Inspection start date | Feb 7, 2022 |
| 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: