FDA 483 - Summers Laboratories Inc. - December 28, 2012

Summers Laboratories, Inc. in Collegeville, PA, an own label finished drug distributor, was inspected from December 18-28, 2012. The inspection revealed significant deficiencies across multiple quality system elements, including inadequate complaint investigations, lack of proper quality unit procedures and change control, insufficient stability testing, and improper storage conditions for drug products. These findings indicate a systemic failure to adhere to good manufacturing practices for drug product distribution and quality control.