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•United States

Zenflow, Inc., South San Francisco, CA – FDA Inspections

Inspection records and compliance data for Zenflow, Inc. in South San Francisco, California. 2 FDA inspections on record, 2 Form 483s, last inspected October 30, 2025.

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Company Profile

This profile covers Zenflow, Inc. based in South San Francisco, California, United States.

FDA Inspection History

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

First inspected June 6, 2025. Last inspected October 30, 2025.

Most cited issue areas

  • Design input - documentation1 inspection
  • Design Validation - Risk analysis not performed/inadequate1 inspection
  • Lack of or inadequate procedures1 inspection

FDA inspections (2)

DateResultFDA center(s)Insp. #
October 30, 2025VAIMedical Devices & Rad Health · Product Evaluation: Medical Devices1290048
June 6, 2025VAIMedical Devices & Rad Health · Product Evaluation: Medical Devices1273304
FDA documents

Form 483s (2)

  • Form 483s · October 30, 2025
  • Form 483s · June 6, 2025
People (4)
Korina Serrano
Person
Cynthia J. Tsui
Person
Nga T. Ho
Person
Kevin T. Le
Person
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Company Information

Name

Zenflow, Inc.

FEI Number

3014211785

Address

395 Oyster Point Blvd Ste 501, South San Francisco, California 94080, United States

Country

United States

ID: 8f15f8d4-6913-41a1-ad98-74860c35d1eb

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