Warning letter
Maria A. Carballosa, M.D.: warning letter of Dec 12, 2025
FDA warning letter 720805 · Center for Drug Evaluation and Research (CDER)
Key facts
| Reference number | 720805 |
|---|---|
| Company | Maria A. Carballosa, M.D. |
| Subject | In Vivo Bioavailability-Bioequivalence Studies – Clinical |
| Issue date | Dec 12, 2025 |
| Posted date | Dec 23, 2025 |
| Issuing office | Center for Drug Evaluation and Research (CDER) |
| Product type | Drugs |
| CFR sections cited | 312, 312.62(c) |
| Inspection city | Hialeah |
| Inspection ZIP | 33012 |
| Inspection start date | Mar 4, 2025 |
| 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: