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•United States

3D Diagnostix Inc., Allston, MA – FDA Inspections

Inspection records and compliance data for 3D Diagnostix Inc. in Allston, Massachusetts. 1 FDA inspection on record, 1 Form 483, last inspected November 21, 2025.

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Company Profile

This profile covers 3D Diagnostix Inc. based in Allston, Massachusetts, United States.

FDA Inspection History

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

Inspected November 21, 2025.

Most cited issue areas

  • Design history file1 inspection
  • Environmental control Lack of or inadequate procedures1 inspection
  • Lack of or inadequate complaint procedures1 inspection

FDA inspections (1)

DateResultFDA center(s)Insp. #
November 21, 2025VAIMedical Devices & Rad Health · Compliance: Medical Devices1292268
FDA documents

Form 483s (1)

  • Form 483s · November 21, 2025
People (1)
Sunita Pandey
Person
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Neosoma, Inc.
Helios Cardio Inc.
Biotechne, Inc.
Company Information

Name

3D Diagnostix Inc.

FEI Number

3011429437

Address

24 Denby Rd Ste 148, Allston, Massachusetts 02134, United States

Country

United States

ID: 6904bc5d-6c04-4b43-8887-3cdffe87aefb

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