Warning letter
STI Pharma LLC: warning letter of Nov 21, 2016
FDA warning letter 505343 · Philadelphia District Office
Key facts
| Reference number | 505343 |
|---|---|
| Company | STI Pharma LLC |
| Subject | Postmarketing Adverse Drug Experience Reporting Requirements |
| Issue date | Nov 21, 2016 |
| Posted date | Nov 28, 2016 |
| Issuing office | Philadelphia District Office |
| Product type | Drugs |
| CFR sections cited | 314.80, 314.80(a), 314.80(c)(2)(iii), 314.80(b), 314.80(d), 314.80(e), 314.98(a) |
| Inspection city | Newtown |
| Inspection ZIP | 18940 |
| Inspection start date | Jul 11, 2016 |
| Letter on fda.gov | web.archive.org |
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: