Warning letter
Choice All Natural, Inc. dba Om Botanical: warning letter of Oct 21, 2024
FDA warning letter 685615 · Center for Drug Evaluation and Research (CDER)
Key facts
| Reference number | 685615 |
|---|---|
| Company | Choice All Natural, Inc. dba Om Botanical |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Oct 21, 2024 |
| Posted date | Oct 29, 2024 |
| Issuing office | Center for Drug Evaluation and Research (CDER) |
| Product type | Drugs |
| CFR sections cited | 211.137(a), 211.165(a), 207.57(b), 207.57(b)(2), 201.128, 207, 207.29, 211.34, 207.17(a), 211.56(a) |
| Inspection city | Apex |
| Inspection ZIP | 27539 |
| Inspection start date | Jan 17, 2024 |
| 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: