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NorthStar Medical Radioisotopes, LLC — FDA Facility Profile

FEI 3012789825

NorthStar Medical Radioisotopes, LLC is an FDA-inspected facility (FEI 3012789825) located in Columbia, MO, US. RegDataLab tracks 1 FDA inspection at this facility.

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What FDA found at this site

Latest inspection
Aug 14, 2019: Voluntary Action Indicated (VAI)
Inspections on record
1 (1 VAI)
Last OAI inspection
None on record
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Aug 14, 2019Voluntary Action Indicated (VAI)Procedures not in writing, fully followed (21 CFR 211.22(d))
Calibration/Inspection/Checking not done (21 CFR 211.68(a))
Investigations of discrepancies, failures (21 CFR 211.192)
Control procedures to monitor and validate performance (21 CFR 211.110(a))
and 1 more

Facility details

Company
NorthStar Medical Radioisotopes, LLC
Location
Columbia, MO (US)
Source
inspections

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.