Warning letter
Andapharm, LLC: warning letter of Feb 28, 2019
FDA warning letter 566492 · Dallas District Office
Key facts
| Reference number | 566492 |
|---|---|
| Company | Andapharm, LLC |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Feb 28, 2019 |
| Posted date | Mar 5, 2019 |
| Issuing office | Dallas District Office |
| Product type | Drugs |
| CFR sections cited | 211.34, 211.42(c), 211.67(b), 211.100(b), 211.166(a) |
| Inspection city | Fort Lauderdale |
| Inspection ZIP | 33309 |
| Inspection start date | Jul 10, 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: