Drug factory · FDA FEI 3002806423

NTP Radioisotopes

ELIAS MOTSOALEDI ST EXT, R104 PELINDABA BRITS MAGISTERIAL DI MAD, Brits, South Africa

South Africa: 1

Problems found, fixed voluntarily at FDA's last inspection, Apr 11, 2025.

Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.

4 drug inspections on record since 2011: 0 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
Technetium Tc-99m PertechnetateMakes the active ingredient Lantheus Medical Imaging, Inc., Shine Spect USA, LLC 11994-090, 11994-091, 87333-090 +1

FDA inspection history

EndedResultProgramProblems noted
Apr 11, 2025Problems found, fixed voluntarilyDrug Quality Assurance—
Oct 25, 2019Problems found, fixed voluntarilyDrug Quality Assurance—
Oct 31, 2014Problems found, fixed voluntarilyDrug Quality Assurance—
Mar 4, 2011Problems found, fixed voluntarilyDrug Quality Assurance—

Registered with FDA for: api manufacture.