FDA 483 - Altaire Pharmaceuticals, Inc. - March 09, 2017

An FDA inspection of Altaire Pharmaceuticals, Inc., a sterile ophthalmic manufacturer in Aquebogue, NY, revealed significant deficiencies across multiple areas. Observations included failures in aseptic manufacturing procedures, incomplete laboratory records, inadequate laboratory controls for microbial testing and environmental monitoring, and a lack of validated manufacturing processes. Additionally, the firm's complaint handling procedures were found to be deficient, lacking proper review and trending analysis.