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•United States

Izun Pharmaceuticals Corporation, New York, NY – FDA Inspections

Inspection records and compliance data for Izun Pharmaceuticals Corporation in New York, New York. 2 FDA inspections on record, 1 Form 483, last inspected April 11, 2022.

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Company Profile

This profile covers Izun Pharmaceuticals Corporation based in New York, New York, United States.

FDA Inspection History

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

First inspected November 29, 2017. Last inspected April 11, 2022.

Most cited issue areas

  • Design changes - Lack of or Inadequate Procedures1 inspection
  • Design validation - Risk analysis1 inspection
  • Lack of Written MDR Procedures1 inspection

FDA inspections (2)

DateResultFDA center(s)Insp. #
April 11, 2022NAIMedical Devices & Rad Health · Compliance: Devices1167954
November 29, 2017VAIMedical Devices & Rad Health · Compliance: Devices1036992
FDA documents

No Form 483s, Warning Letters or EIRs on record.

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ReCor Medical Inc.
Company Information

Name

Izun Pharmaceuticals Corporation

FEI Number

3008510523

Address

1 Rockefeller Plz Fl 11, New York, New York 10020, United States

Country

United States

ID: 2db172e4-4e27-4f22-8b37-766e9c833203

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