FDA Inspection
ZiphyCare, Inc.ZiphyCare, Inc. – FDA Inspection, Oct 25, 2018
Record Details
This FDA Inspection record concerns ZiphyCare, Inc., with an inspection on October 25, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · ff1dd01c-9193-40f3-9b0b-b1aa8c8b4394
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1069728
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of ZiphyCare, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| July 30, 2025 | VAI | New York District Office | Compliance: Medical Devices |
| September 6, 2022 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 2, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for ZiphyCare, Inc.
- FDA Inspection 1276945 - 2025-07-30
- FDA Inspection 1178942 - 2022-09-06
- FDA Inspection 948362 - 2015-11-02
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