FDA 483 - Kindeva Drug Delivery Limited - August 12, 2016

An FDA inspection of 3M Health Care, Ltd. in Loughborough, UK, revealed significant deficiencies in computer system controls and adherence to established laboratory procedures. The firm failed to maintain complete electronic data, ensure data integrity, and implement proper backup protocols for critical testing equipment. These issues indicate a lack of control over master production and control records, impacting product quality assurance.