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•United States

Sunshine USA, LLC, Johnson City, TN – FDA Inspections

Inspection records and compliance data for Sunshine USA, LLC in Johnson City, Tennessee. 7 FDA inspections on record (2 OAI), 2 Form 483s, last inspected April 28, 2025.

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Company Profile

This profile covers Sunshine USA, LLC based in Johnson City, Tennessee, United States.

FDA Inspection History

FDA inspections
7
OAI
2
VAI
5
NAI
0
Form 483s
2
Warning letters
0

First inspected January 15, 2010. Last inspected April 28, 2025.

Most cited issue areas

  • Lack of or inadequate complaint procedures3 inspections
  • Calibration, Inspection, etc. Procedures Lack of or Inadequ2 inspections
  • Certification not based on adequate test/testing program2 inspections

FDA inspections (7)

DateResultFDA center(s)Insp. #
April 28, 2025VAIMedical Devices & Rad Health · Compliance: Medical Devices1268194
August 17, 2023VAIMedical Devices & Rad Health · Compliance: Devices1215779
November 19, 2015VAIMedical Devices & Rad Health · Compliance: Devices948861
June 14, 2013OAIMedical Devices & Rad Health · Compliance: Devices837378
January 25, 2012OAIMedical Devices & Rad Health · Radiation Control and Health Safety Act765527
March 4, 2011VAIMedical Devices & Rad Health · Compliance: Devices733202
January 15, 2010VAIMedical Devices & Rad Health · Radiation Control and Health Safety Act662576
FDA documents

Form 483s (2)

  • Form 483s · April 28, 2025
  • Form 483s · August 17, 2023
People (1)
Benjamin E. Bowen
Person
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Company Information

Name

Sunshine USA, LLC

FEI Number

3009973354

Address

2225 Eddie Williams Rd, Johnson City, Tennessee 37601, United States

Country

United States

ID: 4724638f-82f9-4efc-b8ca-eafefada4cf8

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