FDA 483 - Chartwell Pharmaceuticals Carmel LLC - December 20, 2024

An FDA inspection of Chartwell Pharmaceuticals Carmel LLC in Carmel, NY, revealed significant deficiencies in manufacturing practices. Observations included inadequate controls to prevent penicillin cross-contamination, incomplete equipment performance qualifications, and insufficient cleaning procedures for manufacturing equipment. These issues indicate a risk to drug product safety, identity, strength, quality, and purity.