FDA 483 - MSN Laboratories Private Ltd. - June 23, 2016

MSN Laboratories Private Limited in Telangana, India, an Active Pharmaceutical Ingredient (API) manufacturer, was cited for significant quality system deficiencies. Observations included a failure to investigate numerous instances of invalid HPLC/GC analysis and reprocessed chromatograms, as well as inadequate control over temperature-sensitive raw materials. Additionally, the firm failed to ensure appropriate transport and storage conditions for APIs shipped internationally to the US market.