FDA 483 - Zydus Lifesciences Limited - August 10, 2018

Watson Pharma Pvt. Ltd. in Ambernath Thane, India, a manufacturer, was cited with four observations during an FDA inspection. The observations highlight significant deficiencies in manufacturing process validation, control over critical raw material dispensing, completeness of material handling procedures, and adherence to laboratory controls and documentation practices. These issues indicate a lack of robust quality systems impacting product quality assurance.