Warning letter
Elemental Herbs Inc. d/b/a ALL good: warning letter of Oct 20, 2023
FDA warning letter 654879 · Division of Pharmaceutical Quality Operations IV
Key facts
| Reference number | 654879 |
|---|---|
| Company | Elemental Herbs Inc. d/b/a ALL good |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Oct 20, 2023 |
| Posted date | Nov 21, 2023 |
| Issuing office | Division of Pharmaceutical Quality Operations IV |
| Product type | Drugs |
| CFR sections cited | 211.166(a), 201.66, 201.128, 211.34, 310.545, 330, 330.2, 211.22(a), 310.545(a)(18)(i) |
| Inspection city | Morro Bay |
| Inspection ZIP | 93442 |
| Inspection start date | Jan 23, 2023 |
| 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: