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•United States

Jatex, Inc., Nappanee, IN – FDA Inspections

Inspection records and compliance data for Jatex, Inc. in Nappanee, Indiana. 2 FDA inspections on record, 2 Form 483s, last inspected February 18, 2026.

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Company Profile

This profile covers Jatex, Inc. based in Nappanee, Indiana, United States.

FDA Inspection History

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

First inspected June 15, 2023. Last inspected February 18, 2026.

Most cited issue areas

  • Lack of or inadequate complaint procedures1 inspection
  • Procedure for nonconforming product not documented1 inspection
  • Process control procedures, Lack of or inadequate procedures1 inspection

FDA inspections (2)

DateResultFDA center(s)Insp. #
February 18, 2026VAIMedical Devices & Rad Health · Compliance: Medical Devices1303422
June 15, 2023NAIMedical Devices & Rad Health · Postmarket Assurance: Devices1208746
FDA documents

Form 483s (1)

  • Form 483s · June 15, 2023
People (1)
Suyang Qin
Person
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Company Information

Name

Jatex, Inc.

FEI Number

3010049501

Address

551 Shawnee St, Nappanee, Indiana 46550, United States

Country

United States

ID: caeeba3c-f522-4d45-a766-4d53ac49e473

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