FDA 483 - Lee Pharma Ltd. - November 02, 2018

An FDA inspection of Lee Pharma Limited, a manufacturer in Hyderabad, India, revealed significant deficiencies in their quality control systems. The firm was cited for failing to validate analytical methods used for process validation and stability samples, and for inadequate storage conditions and packaging simulation for stability samples. Additionally, the inspection found issues with establishing reexamination periods for packaging materials and with written procedures lacking sufficient detail for consistent implementation.