FDA 483 - BioSurg, Inc. - April 19, 2019

An FDA inspection of BioSurg, Inc., a nonclinical laboratory in Winters, CA, from April 15-19, 2019, revealed several significant deficiencies. Findings included non-adherence to study protocols, failure to properly archive study specimens, and inadequate retention of reserve samples. Additionally, the firm failed to authorize and document deviations from standard operating procedures, specifically regarding out-of-range refrigerator temperatures for test articles.