Warning letter
Stonegate Pharmacy LP: warning letter of Nov 10, 2016
FDA warning letter 505526 · Dallas District Office
Key facts
| Reference number | 505526 |
|---|---|
| Company | Stonegate Pharmacy LP |
| Subject | Compounding Pharmacy/Adulteration/Misbranding |
| Issue date | Nov 10, 2016 |
| Posted date | Nov 29, 2016 |
| Issuing office | Dallas District Office |
| Product type | Drugs |
| CFR sections cited | 211.166(a), 201.115, 211.192, 211.28(a), 211.42(c)(10)(iv), 211.42(c)(10)(v), 211.113(b), 211.167(a) |
| Inspection city | Austin |
| Inspection ZIP | 78745 |
| Inspection start date | Feb 23, 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: