Warning letter
Actavis Laboratories FL, Inc.: warning letter of Feb 1, 2019
FDA warning letter 567857 · Dallas District Office
Key facts
| Reference number | 567857 |
|---|---|
| Company | Actavis Laboratories FL, Inc. |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Feb 1, 2019 |
| Posted date | Mar 5, 2019 |
| Issuing office | Dallas District Office |
| Product type | Drugs |
| CFR sections cited | 211.34, 211.192, 211.22(a), 211.100(a), 211.110(a) |
| Inspection city | Davie |
| Inspection ZIP | 33314 |
| Inspection start date | Jul 9, 2018 |
| 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: