Warning letter
Anne’s Daye Ltd dba Tampon Innovations: warning letter of Dec 17, 2024
FDA warning letter 696362 · Center for Devices and Radiological Health
Key facts
| Reference number | 696362 |
|---|---|
| Company | Anne’s Daye Ltd dba Tampon Innovations |
| Subject | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device |
| Issue date | Dec 17, 2024 |
| Posted date | Dec 24, 2024 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 807.81(a)(3)(i), 807.81(a)(3)(ii), 807.81(b) |
| Inspection city | Iliyantsi |
| Inspection start date | Jul 8, 2024 |
| 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: