FDA EIR - Kindeva Drug Delivery Limited - March 05, 2015

An FDA Good Manufacturing Practice (GMP) inspection of 3M Health Care, Ltd., located at 3M House, Morley Street Loughborough, was conducted from March 2 to March 5, 2015. This inspection, requested by CDER and performed under CP 7356.002 "Drug Manufacturing Inspections," focused on the firm's non-sterile dosage form manufacturing for the US market. The previous inspection in April 2013 had identified three significant issues, resulting in an FDA-483: a failure to implement corrective actions, lack of individual equipment logs, and outdated laboratory methods. These prior commitments were reviewed during the current inspection. The 2015 inspection adopted a systems-based approach, evaluating quality, production, materials, packaging & labeling, and laboratory operations. No formal violations (FDA-483) were issued during this latest visit, though some matters were discussed with management. The FDA recommended classifying this inspection as "No Action Indicated," signifying a satisfactory outcome without requiring specific corrective actions from the company.