FDA 483 - Valens Molecules Private Limited - July 29, 2016

An FDA inspection of Resh Chemicals Private Limited in Malkajgiri, Hyderabad, India, an API manufacturer, revealed significant deficiencies in their quality systems. Observations included inadequate investigations into out-of-specification results, use of unqualified equipment, and incomplete laboratory and batch production records. The firm also failed to review electronically recorded quality data, indicating a lack of robust control over critical manufacturing and quality processes.