Warning letter
Purolea Cosmetics Lab: warning letter of Apr 2, 2026
FDA warning letter 722591 · Center for Drug Evaluation and Research (CDER)
Key facts
| Reference number | 722591 |
|---|---|
| Company | Purolea Cosmetics Lab |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug |
| Issue date | Apr 2, 2026 |
| Posted date | Apr 14, 2026 |
| Issuing office | Center for Drug Evaluation and Research (CDER) |
| Product type | Drugs |
| CFR sections cited | 201.128, 207.29(a)(1), 207.57(b)(1)(ii), 211.22, 211.22(a), 211.22(c), 211.22(d), 211.34, 211.84(d)(1), 211.100, 211.100(a), 211.165(b) |
| Inspection city | Livonia |
| Inspection ZIP | 48150-1109 |
| Inspection start date | Oct 28, 2025 |
| Letter on fda.gov | fda.gov |
At a glance
- 10–99 CFR sections cited
- 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: