Warning letter
Burzynski Research Institute: warning letter of Dec 3, 2013
FDA warning letter 414796 · Center for Drug Evaluation and Research
Key facts
| Reference number | 414796 |
|---|---|
| Company | Burzynski Research Institute |
| Subject | Sponsor/Monitor/Contract Research Organization |
| Issue date | Dec 3, 2013 |
| Posted date | Dec 3, 2013 |
| Issuing office | Center for Drug Evaluation and Research |
| Product type | Drugs |
| CFR sections cited | 54, 50, 50.25(b)(3), 312, 312.50, 312.30(b)(1)(ii), 312.56(a), 312.62(b), 312.53(c)(4) |
| Inspection city | Houston |
| Inspection ZIP | 77055 |
| Inspection start date | Jan 17, 2013 |
| 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: