Warning letter
Indiana Lions Eye Bank, Inc. dba VisionFirst Indiana Lions Eye Bank: warning letter of Jun 10, 2024
FDA warning letter 680039 · Division of Biological Products Operations II
Key facts
| Reference number | 680039 |
|---|---|
| Company | Indiana Lions Eye Bank, Inc. dba VisionFirst Indiana Lions Eye Bank |
| Subject | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) |
| Issue date | Jun 10, 2024 |
| Posted date | Jun 25, 2024 |
| Issuing office | Division of Biological Products Operations II |
| Product type | Biologics |
| CFR sections cited | 1271, 1271.47(a), 1271.75(a)(1), 1271.350(b), 1271.75(d) |
| Inspection city | Carmel |
| Inspection ZIP | 46280-2818 |
| Inspection start date | Jan 22, 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: