FDA 483 - Kindeva Drug Delivery Limited - April 15, 2013

An FDA inspection of 3M Health Care, Ltd. in Loughborough, United Kingdom, identified significant issues in their pharmaceutical manufacturing processes. Observations included reactive drug product containers leading to product delivery failures, inadequate analytical equipment logbooks lacking essential batch information, and a failure by the Quality Control Unit to formally approve changes to analytical test procedures for over six years. These findings highlight deficiencies in quality control and manufacturing oversight.