Antacid Maker Gets Form 483 for Poor Probes Into Bad, Smelly Batches

October 2, 2012
Brioschi Pharmaceuticals, a maker of antacid products, was handed a Form 483 for lax investigations into out-of-specification lots released to market and complaints of odiferous drugs. Brioschi’s quality control unit failed to further investigate or reject one lot of tartaric acid that tested out of specification and that was later used in more than 30 product lots, the form states.
Drug GMP Report