FDA EIR - WUXI JINGHAI AMINO ACID CO., LTD - May 20, 2014

An FDA inspection of WUXI JINGHAI AMINO ACID CO., LTD in Wuxi, China, took place from May 19-20, 2014. The inspection was conducted under the IOG-FY'14 Workplan and Compliance Program 7303.803, focusing on the firm’s bulk dietary supplement ingredient manufacturing operations. The company, which is registered as a USFDA Food Facility and also operates under China's Active Pharmaceutical Ingredient (API) regulations, underwent a review of its food Good Manufacturing Practice (GMP) records. These included documentation for raw materials, production, testing, training, and pest control. Importantly, the inspection concluded without the issuance of any formal observations (FDA-483), indicating that no significant compliance issues were identified. While the investigator suggested improvements regarding hand drying devices, to which the firm committed, no formal violations or mandatory corrective actions were imposed by the FDA. The company demonstrated established quality systems and third-party certifications, such as ISO 9001:2008 and ISO 22000:2005.