The Quality Lowdown: Warning Letters, Nitrosamine Recalls And Sen. Warren's Generics Manufacturing Plan

Manufacturers warned on quality basics like testing and keeping records and reminded about nitrosamine deadlines; Senator Elizabeth Warren clarifies government drug manufacturing idea.

The Quality Lowdown

A trio of warning letters, some analysis and advice related to the discovery of nitrosamine impurities in various medications, and a clarification by one of the US presidential candidates on her plan for public-sector pharmaceutical manufacturing are featured in this latest edition of the Quality Lowdown.

The warning letters to over-the-counter drug manufacturers on three continents highlighted comparable types of failures in basic drug good manufacturing...

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