Warning letter
AG Essence, Inc.: warning letter of Jun 14, 2024
FDA warning letter 678344 · Center for Devices and Radiological Health
Key facts
| Reference number | 678344 |
|---|---|
| Company | AG Essence, Inc. |
| Subject | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device |
| Issue date | Jun 14, 2024 |
| Posted date | Jul 9, 2024 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 3.2(e), 801, 801.3, 830, 830.3, 801.40(a)(1), 801.40(a)(2), 801.20(a), 830.300(a), 807.81(b) |
| Inspection city | Sandston |
| Inspection ZIP | 23150 |
| Inspection start date | Jan 9, 2024 |
| Letter on fda.gov | fda.gov |
At a glance
- 10–99 CFR sections cited
- OAI Linked inspection classification
- Yes Form FDA 483 issued
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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: