FDA 483 - Chartwell Pharmaceuticals Carmel LLC - December 16, 2019

Bennett Company, Inc. in Carmel, NY, was cited for significant deficiencies during an FDA inspection. Observations included inadequate written procedures for cleaning and maintenance, a lack of formal performance qualification for manufacturing equipment, and failures to submit timely Field Alert Reports for out-of-specification drug products. These issues indicate potential risks to product quality and regulatory compliance.