483
Solara Active Pharma Sciences LimitedSolara Active Pharma Sciences Limited – FDA 483, Jul 27, 2018
Record Details
An FDA inspection of Solara Active Pharma Sciences Limited in New Mangalore, Karnataka, India, revealed significant deficiencies in their manufacturing and laboratory controls. Observations included inadequate written procedures for equipment cleaning and a lack of validation for cleaning processes. Additionally, the firm's method validation for forced degradation studies of active pharmaceutical ingredients was found to be insufficient.
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ID · da093bd6-125e-4649-a293-686bc2779480
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