Warning letter
Osmosis, LLC: warning letter of Aug 23, 2023
FDA warning letter 652059 · Division of Human and Animal Food Operations East IV
Key facts
| Reference number | 652059 |
|---|---|
| Company | Osmosis, LLC |
| Subject | Unapproved New Drugs/Misbranded |
| Issue date | Aug 23, 2023 |
| Posted date | Sep 5, 2023 |
| Issuing office | Division of Human and Animal Food Operations East IV |
| Product type | Food/Cosmetics |
| CFR sections cited | 101.9(b), 21, 101.36, 101.93, 111, 111.103, 111.453, 111.503, 111.553, 111.560, 101.3(d), 101.36(e)(1) and 12 more |
| Inspection city | Evergreen |
| Inspection ZIP | 80439 |
| Inspection start date | Jan 5, 2023 |
| 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: