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•United States

NorthStar Medical Radioisotopes, LLC, Columbia, MO – FDA Inspections

Inspection records and compliance data for NorthStar Medical Radioisotopes, LLC in Columbia, Missouri. 2 FDA inspections on record, 2 Form 483s, last inspected August 14, 2019.

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Company Profile

This profile covers NorthStar Medical Radioisotopes, LLC based in Columbia, Missouri, United States.

FDA Inspection History

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

First inspected June 15, 2017. Last inspected August 14, 2019.

Most cited issue areas

  • Calibration/Inspection/Checking not done1 inspection
  • Control procedures to monitor and validate performance1 inspection
  • Investigations of discrepancies, failures1 inspection

FDA inspections (2)

DateResultFDA center(s)Insp. #
August 14, 2019VAIHuman Drugs · Drug Quality Assurance1101973
June 15, 2017Not classifiedHuman Drugs1015065
FDA documents

Form 483s (2)

  • Form 483s · January 16, 2020
  • Form 483s · August 14, 2019
People (3)
Jonathan G Gayechuway
Person
Simone E. Pitts
Person
Michele Perry-Williams
Person
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Company Information

Name

NorthStar Medical Radioisotopes, LLC

FEI Number

3012789825

Address

1513 Research Park Dr Ste 299, Columbia, Missouri 65211, United States

Country

United States

ID: 50ac465e-bd36-475f-ad12-d814e8bdedf3

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