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ZiphyCare, Inc., New York, NY – FDA Inspections

Inspection records and compliance data for ZiphyCare, Inc. in New York, New York. 4 FDA inspections on record, 2 Form 483s, last inspected July 30, 2025.

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Company Profile

This profile covers ZiphyCare, Inc. based in New York, New York, United States.

FDA Inspection History

FDA inspections
4
OAI
0
VAI
3
NAI
1
Form 483s
2
Warning letters
0

First inspected November 2, 2015. Last inspected July 30, 2025.

Most cited issue areas

  • Lack of Written MDR Procedures3 inspections
  • Complaints1 inspection
  • Design control - no procedures1 inspection

FDA inspections (4)

DateResultFDA center(s)Insp. #
July 30, 2025VAIMedical Devices & Rad Health · Compliance: Medical Devices1276945
September 6, 2022NAIMedical Devices & Rad Health · Postmarket Assurance: Devices1178942
October 25, 2018VAIMedical Devices & Rad Health · Compliance: Devices1069728
November 2, 2015VAIMedical Devices & Rad Health · Compliance: Devices948362
FDA documents

Form 483s (2)

  • Form 483s · July 30, 2025
  • Form 483s · September 6, 2022
People (2)
Colin E. Tack
Person
Kwong P. Lee
Person
Related Companies (10)

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Company Information

Name

ZiphyCare, Inc.

FEI Number

3011682748

Address

205 W 37th St # 6111, New York, New York 10018, United States

Country

United States

ID: 67728440-e098-45ca-b2d1-12551fabca84

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