FDA 483 - Biological E. Limited - October 08, 2021

Biological E. Limited in Hyderabad, India, an API and finished drug manufacturer, received a Form 483 with six observations primarily concerning significant deficiencies in quality control, data integrity, and equipment management. Issues included failures to investigate discrepancies, inadequate computer system controls, poor equipment cleaning, and non-adherence to stability testing and quality unit procedures. These findings indicate a systemic lack of adherence to cGMP requirements, posing risks to drug product quality and purity.