Warning letter
US Specialty Formulations LLC: warning letter of Sep 30, 2016
FDA warning letter 489914 · Philadelphia District Office
Key facts
| Reference number | 489914 |
|---|---|
| Company | US Specialty Formulations LLC |
| Subject | Compounding Pharmacy/Adulterated Drug Products |
| Issue date | Sep 30, 2016 |
| Posted date | Oct 18, 2016 |
| Issuing office | Philadelphia District Office |
| Product type | Drugs |
| CFR sections cited | 201.115, 211.192, 211.28(a), 211.113(b), 211.165(a), 211.167(a) |
| Inspection city | Allentown |
| Inspection ZIP | 18103 |
| Inspection start date | May 11, 2015 |
| 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: