Warning letter
Quality CDMO, Inc.: warning letter of Sep 11, 2024
FDA warning letter 665961 · Center for Drug Evaluation and Research (CDER)
Key facts
| Reference number | 665961 |
|---|---|
| Company | Quality CDMO, Inc. |
| Subject | Unapproved New Drugs |
| Issue date | Sep 11, 2024 |
| Posted date | Sep 17, 2024 |
| Issuing office | Center for Drug Evaluation and Research (CDER) |
| Product type | Drugs |
| CFR sections cited | 201.128 |
| Inspection city | Fort Worth |
| Inspection ZIP | 76115 |
| Inspection start date | Jun 12, 2023 |
| Letter on fda.gov | fda.gov |
At a glance
- 1–9 CFR sections cited
- VAI 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: