Warning letter
Brenntag Great Lakes, LLC: warning letter of Oct 26, 2023
FDA warning letter 660268 · Division of Pharmaceutical Quality Operations III
Key facts
| Reference number | 660268 |
|---|---|
| Company | Brenntag Great Lakes, LLC |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Oct 26, 2023 |
| Posted date | Nov 21, 2023 |
| Issuing office | Division of Pharmaceutical Quality Operations III |
| Product type | Drugs |
| CFR sections cited | 211.67(b), 211.22, 211.34, 211.22(a), 211.68(b), 211.100(a), 211.180(e) |
| Inspection city | Menomonee Falls |
| Inspection ZIP | 53051 |
| Inspection start date | Apr 26, 2023 |
| 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: