FDA 483 - West China-Frontier Pharma Tech Co., Ltd. - April 21, 2017

West China-Frontier Pharma Tech Co., Ltd. in Chengdu, China, a nonclinical laboratory, received a Form 483 with four observations during an FDA inspection. The inspection revealed deficiencies in the study director's oversight of experimental data, inadequate documentation for changes in automated data entries, and failures within the quality assurance unit. Additionally, the firm lacked established standard operating procedures for the handling and storage of test and control articles, including expired materials and labeling updates.