483
Chartwell Pharmaceuticals Carmel LLCFDA 483 - Chartwell Pharmaceuticals Carmel LLC - December 20, 2024
Record Details
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.
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ID · 6f18c8a4-903a-4d41-a3c7-07e7650a7b6c