Warning letter
Jon B. Cole, MD: warning letter of May 5, 2021
FDA warning letter 611902 · Center for Drug Evaluation and Research | CDER
Key facts
| Reference number | 611902 |
|---|---|
| Company | Jon B. Cole, MD |
| Subject | Failure to obtain Investigational New Drug Applications |
| Issue date | May 5, 2021 |
| Posted date | Oct 19, 2021 |
| Issuing office | Center for Drug Evaluation and Research | CDER |
| Product type | Drugs |
| CFR sections cited | 56, 50, 312, 312.2, 312.7, 312.20, 312.2(a), 312.2(b)(1)(iii), 312.2(d), 312.3(b), 312.2(b), 312.2(b)(1) |
| Inspection city | Minneapolis |
| Inspection ZIP | 55415 |
| Inspection start date | Apr 10, 2019 |
| Letter on fda.gov | fda.gov |
At a glance
- 10–99 CFR sections cited
- OAI Linked inspection classification
- Yes Form FDA 483 issued
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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: