Warning letter
Phi Sciences: warning letter of Jan 30, 2019
FDA warning letter 566043 · Center for Drug Evaluation and Research
Key facts
| Reference number | 566043 |
|---|---|
| Company | Phi Sciences |
| Subject | Unapproved New Drugs/Misbranded |
| Issue date | Jan 30, 2019 |
| Posted date | Mar 12, 2019 |
| Issuing office | Center for Drug Evaluation and Research |
| Product type | Food/Cosmetics |
| CFR sections cited | 101, 101.5, 101.36, 111, 111.55, 111.103, 111.105, 111.453, 101.3(g), 101.7(b)(1), 101.7(j)(3), 101.4(g) and 8 more |
| Inspection city | Cottonwood |
| Inspection ZIP | 86326 |
| Inspection start date | Aug 10, 2018 |
| 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: