FDA 483 - Ningbo Smart Pharmaceutical Co., Ltd. - October 29, 2010

Ningbo Smart Pharmaceutical Co Ltd, a drug substance manufacturer in Ningbo, P.R. China, was cited for multiple significant deficiencies during an FDA inspection. The observations primarily concern inadequate laboratory controls, including a lack of raw data for Certificates of Analysis, insufficient raw material testing, and unapproved qualification documents. These issues indicate a systemic failure in quality control and data integrity for API products shipped to the US market.