FDA Inspection
ZiphyCare, Inc.ZiphyCare, Inc. – FDA Inspection, Nov 2, 2015
Record Details
This FDA Inspection record concerns ZiphyCare, Inc., with an inspection on November 2, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- ZiphyCare, Inc.
- Inspection Date
- November 2, 2015
- Product Type
- Devices
View Company Profile
ID · 49ce59bd-d20a-4d74-8942-a63092d681bc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 948362
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.198(a)Complaints
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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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 |
| October 25, 2018 | 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 1069728 - 2018-10-25
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