FDA 483 - Anqing Jiaxiin Medical Technology Co., Ltd. - October 23, 2019

Anqing Jiaxin Medical Technology Co., Ltd. was cited for three observations during an FDA inspection. The firm failed to adequately establish process control procedures for heat sealers, did not properly control non-conforming products by misapplying its AQL sampling plan, and had inadequate procedures for controlling cleanroom environmental conditions. These issues indicate significant deficiencies in quality system controls for their Class I Cotton Tip Applicator products.