FDA lambasts Kilitch for unsanitary manufacturing conditions and issues warning letter to Natco, too
Fierce Pharma
APRIL 10, 2024
FDA chided Kilitch Healthcare India for “poor practices” tied to written procedures around microbial contamination, shoddy lab records, behaviors that could have caused contamination and quality control lapses. In a four-observation warning letter issued this week, the U.S.
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