FDA 483 - Xiantao Shuangyan Plastics Co., Ltd. - May 02, 2018

Xiantao Shuangyan Plastics Co., Ltd., a foreign Class I medical device manufacturer in Xiantao City, Hubei Province, China, was cited for significant deficiencies during an FDA inspection. The inspection revealed inadequate environmental controls, including widespread contamination in raw material storage and production areas, along with poor hygiene practices and facility maintenance. Additionally, the firm failed to conduct required internal quality audits for several years, indicating a systemic breakdown in their quality management system.