Warning letter
Fuller Industries Inc.: warning letter of Jun 28, 2023
FDA warning letter 654425 · Division of Pharmaceutical Quality Operations III
Key facts
| Reference number | 654425 |
|---|---|
| Company | Fuller Industries Inc. |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Jun 28, 2023 |
| Posted date | Jul 18, 2023 |
| Issuing office | Division of Pharmaceutical Quality Operations III |
| Product type | Drugs |
| CFR sections cited | 211.165(a), 211.180(e), 211.194(a), 211.22, 211.34, 211.192, 211.84(d)(1), 211.160(b), 211.166(a) |
| Inspection city | Great Bend |
| Inspection ZIP | 67530 |
| Inspection start date | Feb 15, 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: