Warning letter
GC America, Inc.: warning letter of May 14, 2026
FDA warning letter 727602 · Center for Drug Evaluation and Research (CDER)
Key facts
| Reference number | 727602 |
|---|---|
| Company | GC America, Inc. |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | May 14, 2026 |
| Posted date | May 26, 2026 |
| Issuing office | Center for Drug Evaluation and Research (CDER) |
| Product type | Food/Cosmetics |
| CFR sections cited | 211.180(e), 211.22(d), 211.34, 211.68(b), 211.84(d)(1), 211.166(a) |
| Inspection city | Alsip |
| Inspection ZIP | 60803-1532 |
| Inspection start date | Nov 3, 2025 |
| Letter on fda.gov | fda.gov |
At a glance
- 1–9 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: