Warning letter
Advanced Pharmaceutical Technology: warning letter of Mar 14, 2025
FDA warning letter 692576 · Center for Drug Evaluation and Research (CDER)
Key facts
| Reference number | 692576 |
|---|---|
| Company | Advanced Pharmaceutical Technology |
| Subject | CGMP/Finished Pharmaceutical/Adulterated |
| Issue date | Mar 14, 2025 |
| Posted date | Mar 18, 2025 |
| Issuing office | Center for Drug Evaluation and Research (CDER) |
| Product type | Drugs |
| CFR sections cited | 314, 211.167(c), 211.100(a), 211.113(b), 4, 211.22(a), 820, 211.34 |
| Inspection city | Elmsford |
| Inspection ZIP | 10523 |
| Inspection start date | Jul 10, 2024 |
| 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: