FDA Inspection
ZiphyCare, Inc.ZiphyCare, Inc. – FDA Inspection, Jul 30, 2025
Record Details
This FDA Inspection record concerns ZiphyCare, Inc., with an inspection on July 30, 2025, issued by the New York District Office, covering medical devices & rad health.
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ID · ec2aa833-ebbb-46fe-bb8e-7e51db1ac5cc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1276945
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
FDA Citations
3- 21 CFR 807.25(g)Device listing information not submitted
- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 820.40(a)Document review, approval documentation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of ZiphyCare, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| September 6, 2022 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 25, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 2, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for ZiphyCare, Inc.
- FDA Inspection 1178942 - 2022-09-06
- FDA Inspection 1069728 - 2018-10-25
- FDA Inspection 948362 - 2015-11-02
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