Warning letter
EUCYT Laboratories LLC: warning letter of Jun 4, 2020
FDA warning letter 607182 · Office of Biological Products Operations - Division II
Key facts
| Reference number | 607182 |
|---|---|
| Company | EUCYT Laboratories LLC |
| Subject | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| Issue date | Jun 4, 2020 |
| Posted date | Jun 12, 2020 |
| Issuing office | Office of Biological Products Operations - Division II |
| Product type | Biologics |
| CFR sections cited | 211.176, 211.192, 312, 211.42(c)(10)(iv), 211.67(b), 211.80(a), 211.100(a), 211.113(b), 211.166(a), 211.188(b), 211.198(a), 1271 and 15 more |
| Inspection city | Las Vegas |
| Inspection ZIP | 89118 |
| Inspection start date | Nov 12, 2019 |
| Letter on fda.gov | fda.gov |
At a glance
- 10–99 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: