Warning letter
US Specialty Formulations, LLC: warning letter of Jul 26, 2023
FDA warning letter 659142 · Division of Pharmaceutical Quality Operations I
Key facts
| Reference number | 659142 |
|---|---|
| Company | US Specialty Formulations, LLC |
| Subject | Compounding Pharmacy/Adulterated Drug Products |
| Issue date | Jul 26, 2023 |
| Posted date | Aug 8, 2023 |
| Issuing office | Division of Pharmaceutical Quality Operations I |
| Product type | Drugs |
| CFR sections cited | 211.166(a), 210.1(b), 211.167(a), 201.115, 211.192, 200.10(b), 211.28(a), 211.42(a), 211.42(c)(10)(iii), 211.42(c)(10)(iv), 211.42(c)(10)(v), 211.113(b) and 2 more |
| Inspection city | Allentown |
| Inspection ZIP | 18103 |
| Inspection start date | Mar 21, 2022 |
| Letter on fda.gov | fda.gov |
At a glance
- 10–99 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: