Quality Lowdown: FDA Defends Nitrosamine Testing Methods While US, EU Enforcement Continues

The crisis of nitrosamine contamination in prescription drug products continues to roil the world’s health authorities and prompts debate on the different approaches used to measure these impurities. Meanwhile, an Austrian firm gets inspected despite the pandemic and yet another homeopathic firm gets an FDA warning letter.

The Quality Lowdown

The discovery of nitrosamine contamination in prescription drugs continued to command regulatory attention in recent weeks.

It prompted the US Food and Drug Administration to explain why it tested and found nitrosamine impurities at lower levels...

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