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•United States

BSN Medical Inc, Charlotte, NC – FDA Inspections

Inspection records and compliance data for BSN Medical Inc in Charlotte, North Carolina. 3 FDA inspections on record, 2 Form 483s, last inspected September 05, 2025.

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Company Profile

This profile covers BSN Medical Inc based in Charlotte, North Carolina, United States.

FDA Inspection History

FDA inspections
3
OAI
0
VAI
2
NAI
1
Form 483s
2
Warning letters
0

First inspected November 8, 2017. Last inspected September 5, 2025.

Most cited issue areas

  • Design validation - simulated testing1 inspection
  • Investigation of device failures1 inspection
  • Lack of or inadequate final acceptance procedures1 inspection

FDA inspections (3)

DateResultFDA center(s)Insp. #
September 5, 2025NAIMedical Devices & Rad Health · Postmarket Assurance: Medical Devices1280555
March 22, 2021VAIMedical Devices & Rad Health · Compliance: Devices1136920
November 8, 2017VAIMedical Devices & Rad Health · Compliance: Devices1030983
FDA documents

Form 483s (2)

  • Form 483s · September 5, 2025
  • Form 483s · March 22, 2021
People (1)
Gamal A. Norton
Person
Related Companies (10)

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410 Medical, Inc.
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Biomerics Precision Concepts Group
Healthplus LLC
Atalys Asheboro LLC
CivaTech Oncology Inc.
D R Burton Healthcare LLC
Comfortland Medical, Inc.
Keranetics Inc.
Company Information

Name

BSN Medical Inc

FEI Number

1038963

Address

5825 Carnegie Blvd, Charlotte, North Carolina 28209, United States

Country

United States

ID: 01f25415-fe2a-4784-be4d-0088803e6f78

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