483
Chartwell Pharmaceuticals Carmel LLCChartwell Pharmaceuticals Carmel LLC – FDA 483, Dec 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
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