FDA 483 - Apnar Pharma LLP - May 22, 2026
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Apnar Pharma LLP in East Windsor, NJ, a drug manufacturer, was cited for two significant cGMP deficiencies during an FDA inspection. Observations included failures in establishing and following quality control unit procedures, specifically regarding cGMP annual refresher training and periodic audit trail reviews for laboratory instruments. Additionally, the firm failed to conduct timely annual product reviews for several drug products and lacked adequate SOPs for these reviews.
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