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

An FDA inspection of Silarx Pharmaceuticals, Inc. in Carmel, NY, was conducted from February 15 to February 28, 2018, focusing on generic prescription and OTC liquid drug manufacturing operations. This routine inspection, guided by CPGM 7356.002 for drug manufacturing, assessed the company's Quality, Facilities & Equipment, Production, and Laboratory Control systems. The inspection resulted in two significant observations documented on an FDA-483, indicating deviations from Good Manufacturing Practices. Firstly, the company's complaint handling procedures (21 CFR 211.198(a)) were found deficient, as Silarx failed to investigate a September 2017 complaint regarding Loratadine Oral Solution. This complaint reported an adverse event (confusion and memory loss) and potential product tampering, yet no formal investigation was initiated by the firm. Secondly, routine checking of critical laboratory equipment (21 CFR 211.68(a)) was inadequate. Specifically, temperatures of refrigerators, freezers, and incubators—used for storing reagents and incubating microbiological media—were not monitored on weekends or non-operational days, meaning potential temperature excursions remained undetected. Silarx Pharmaceuticals was required to submit a written response to the FDA-483 within 15 days. During the inspection, management initiated an investigation into the unaddressed complaint and developed a draft procedure for continuous temperature monitoring of the affected equipment, demonstrating initial steps towards corrective actions.