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•United States

DGI Group LLC, Howell, NJ – FDA Inspections

Inspection records and compliance data for DGI Group LLC in Howell, New Jersey. 1 FDA inspection on record, 1 Form 483, last inspected August 19, 2025.

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Company Profile

This profile covers DGI Group LLC based in Howell, New Jersey, United States.

FDA Inspection History

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

Inspected August 19, 2025.

Most cited issue areas

  • Design output - documentation1 inspection
  • Design plans - Lack of or inadequate1 inspection
  • Design review - Lack of or inadequate procedures1 inspection

FDA inspections (1)

DateResultFDA center(s)Insp. #
August 19, 2025NAIMedical Devices & Rad Health · Postmarket Assurance: Medical Devices1279389
FDA documents

Form 483s (1)

  • Form 483s · August 19, 2025
People (1)
Frank J. Marciniak
Person
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Company Information

Name

DGI Group LLC

FEI Number

3014527929

Address

400 Candlewood Cmns, Howell, New Jersey 07731, United States

Country

United States

ID: 5ebb372f-a4ec-47a9-92bf-fcdc18f1ff98

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