NORTHSTAR MEDICAL RADIOISOTOPES LLC
Overview
NORTHSTAR MEDICAL RADIOISOTOPES LLC is an active pharmaceutical ingredient (API) supplier with 1 active FDA Type II Drug Master File, covering ACTINIUM-225 CHLORIDE (RADIUM-225 DECAY PRODUCT).
Core services & business areas
API / Drug Master Files
NORTHSTAR MEDICAL RADIOISOTOPES LLC holds 1 active (1 total) FDA Type II Drug Master File — identifying it as an active-substance / API supplier. Type II DMFs are filed with the FDA to support the use of an active pharmaceutical ingredient in drug applications.
- ACTINIUM-225 CHLORIDE (RADIUM-225 DECAY PRODUCT)Active2026-03-18
FDA compliance signals
5 FDA enforcement records linked to this company.
- 4832019-08-14
Calibration/Inspection/Checking not done
- 4832019-08-14
Control procedures to monitor and validate performance
- 4832019-08-14
Scientifically sound laboratory controls
- 4832019-08-14
Investigations of discrepancies, failures
- 4832019-08-14
Procedures not in writing, fully followed
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