FDA Inspection 1276945 — ZiphyCare, Inc.
The FDA completed an inspection of ZiphyCare, Inc. on Jul 30, 2025 in New York, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 30, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- New York, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 21453 | 21 CFR 807.25(g) | Device listing information not submitted |
| 3199 | 21 CFR 820.40(a) | Document review, approval documentation |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |