FDA 483 - Apharma, Inc - September 29, 2010

Apharma, Inc. in Salisbury, MD, a non-clinical laboratory, was inspected by the FDA from September 20-29, 2010. The inspection revealed significant deficiencies in record retention, adherence to study protocols, study director oversight, quality assurance unit responsibilities, and equipment calibration and maintenance. These issues indicate a lack of control over critical aspects of non-clinical laboratory studies.