Warning letter
Ignatius P. Godoy, M.D.: warning letter of Oct 1, 2018
FDA warning letter 561662 · Center for Biologics Evaluation and Research
Key facts
| Reference number | 561662 |
|---|---|
| Company | Ignatius P. Godoy, M.D. |
| Subject | Bioresearch Monitoring Program/IRB |
| Issue date | Oct 1, 2018 |
| Posted date | Oct 16, 2018 |
| Issuing office | Center for Biologics Evaluation and Research |
| Product type | Biologics |
| CFR sections cited | 50.20, 50, 312, 312.60, 312.62(b) |
| Inspection city | Paramount |
| Inspection ZIP | 90723 |
| Inspection start date | May 29, 2018 |
| Letter on fda.gov | fda.gov |
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: