Warning letter
Steiner Biotechnology, LLC: warning letter of Feb 3, 2020
FDA warning letter 592280 · Center for Devices and Radiological Health
Key facts
| Reference number | 592280 |
|---|---|
| Company | Steiner Biotechnology, LLC |
| Subject | Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies |
| Issue date | Feb 3, 2020 |
| Posted date | Apr 7, 2020 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 58, 58.202, 58.29(b), 58.35(b)(3), 58.35(c), 58.130(a), 58.130(c) |
| Inspection city | Henderson |
| Inspection ZIP | 89011-3161 |
| Inspection start date | Jun 24, 2019 |
| 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: