Warning letter
Macau-Union Pharmaceutical Limited: warning letter of May 29, 2026
FDA warning letter 724506 · Center for Drug Evaluation and Research (CDER)
Key facts
| Reference number | 724506 |
|---|---|
| Company | Macau-Union Pharmaceutical Limited |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drugs/Misbranded |
| Issue date | May 29, 2026 |
| Posted date | Jun 9, 2026 |
| Issuing office | Center for Drug Evaluation and Research (CDER) |
| Product type | Drugs |
| CFR sections cited | 201.66(b), 201.66(b)(2), 201.128, 211.34, 211.84(d)(1), 211.100(a), 211.137(a), 211.165(a) |
| Inspection city | Macao |
| Inspection start date | Dec 15, 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: