FDA 483 - Neuland Laboratories Limited (Unit I) - June 21, 2019

Neuland Laboratories Limited (Unit I) in Sangareddy, India, an Active Pharmaceutical Ingredient Manufacturer, was cited with five observations during an FDA inspection. The inspection revealed significant issues across data integrity, water system validation, equipment cleaning, and stability study procedures. These failures indicate a lack of adherence to established procedures and inadequate investigation and prevention of deviations.