Warning letter
Thomas E. Young, LLC: warning letter of Apr 20, 2012
FDA warning letter 278418 · Center for Biologics Evaluation and Research
Key facts
| Reference number | 278418 |
|---|---|
| Company | Thomas E. Young, LLC |
| Subject | PHS Act/Violation |
| Issue date | Apr 20, 2012 |
| Posted date | Apr 20, 2012 |
| Issuing office | Center for Biologics Evaluation and Research |
| Product type | Biologics |
| CFR sections cited | 211.182, 211.188, 312, 211.22(a), 211.42(a), 211.67(b), 211.80(a), 211.80(d), 211.100(a), 211.100(b), 211.113(b), 211.160(b) and 10 more |
| Inspection city | Lansdale |
| Inspection ZIP | 19446 |
| Inspection start date | Dec 19, 2011 |
| Letter on fda.gov | web.archive.org |
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: