FDA 483 - Bio-Thera Solutions, Ltd. - August 18, 2023

Bio-Thera Solutions, Ltd. in Huangpu District, Guangzhou City, China, was inspected regarding its manufacturing operations. The inspection revealed deficiencies in environmental monitoring for its RABS vial filling line and inadequate procedures for facility microbial control, specifically concerning sink drain sanitization in production suites. These issues indicate potential risks to product quality and sterility.