Warning letter
University Rx Specialties Inc: warning letter of Sep 28, 2016
FDA warning letter 495985 · Los Angeles District Office
Key facts
| Reference number | 495985 |
|---|---|
| Company | University Rx Specialties Inc |
| Subject | Unapproved New Drug/Compounding/Misbranding/Adulterated |
| Issue date | Sep 28, 2016 |
| Posted date | Oct 18, 2016 |
| Issuing office | Los Angeles District Office |
| Product type | Drugs |
| CFR sections cited | 200.10(b), 201.115, 210, 211, 210.1(b) |
| Inspection city | San Diego |
| Inspection ZIP | 92101 |
| Inspection start date | Aug 13, 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: