FDA 483 - Chartwell Pharmaceuticals Carmel LLC - February 28, 2018

An FDA inspection of Silarx Pharmaceuticals, Inc. in Carmel, NY, a drug product manufacturer, revealed two significant observations. The firm failed to properly handle drug product complaints, specifically neglecting to investigate an adverse reaction report for Loratidine Oral Solution. Additionally, routine equipment checks, including temperature monitoring for critical storage units, were not performed according to a written program on weekends and non-operational days.