Shandong Xinhua Pharmaceuticals (USA) Inc. – FDA EIR, Jun 2, 2021

The FDA conducted an inspection of Shandong Xinhua Pharmaceuticals (USA) Inc., a supplier and warehouse of dietary supplement and pharmaceutical ingredients, on June 2, 2021. This one-day inspection, part of the HAFW5 FY 21 Work Plan/Warehouse Blitz, was conducted under Compliance Program 7303.040 and ORA Field Alert 57, which addresses inspections during the COVID-19 pandemic. The company, based in South El Monte, CA, serves contract manufacturers. During the walkthrough, no discrepancies were noted regarding the storage of dietary supplement ingredients. While a state inspection in 2016 classified the firm as Voluntary Action Indicated due to pest activity, no such issues were observed during this FDA inspection. Furthermore, the firm has established complaint procedures and a recall plan. Significantly, no FDA Form 483 Inspectional Observations were issued, and no discussion items related to non-compliance were raised with management. As a result, no specific regulatory actions or corrective measures were required from the company following this inspection, indicating a satisfactory outcome.