FDA EIR - North China Pharmaceutical Co., Ltd. - May 31, 2013

An FDA surveillance inspection of North China Pharmaceutical Co., Ltd. in Shijiazhuang, China, was conducted from May 27-31, 2013. The inspection, focusing on Current Good Manufacturing Practices (cGMP) for veterinary drugs, followed Compliance Program 7371.001 and ICH Q7A guidance. The primary product for the U.S. market at this site is (b)(4) API. No Form FDA 483, Inspectional Observations, was issued, and the inspection was classified as "No Action Indicated" (NAI). All eight deficiencies noted during the previous inspection (June 28-July 2, 2010), including issues with process validation, cleaning validation, and laboratory controls, were verified as satisfactorily corrected. During the current inspection, five minor deficiencies were discussed with management. These included an unrepresentative statistical sampling plan for incoming raw materials, uncalibrated (b)(4) equipment, and inadequate supplier investigation requirements for raw material non-conformances. Additionally, there was an observation regarding broken insulation on a (b)(4) (which was promptly repaired). The FDA also suggested incorporating more advanced statistical tools, such as control charts, into the annual product review process for better process control evaluation. North China Pharmaceutical Co., Ltd. voluntarily committed to corrective actions. These actions include revising their sampling plan with statistical consultation, qualifying the uncalibrated equipment by October 31, 2013, enhancing equipment maintenance procedures, updating nonconformance procedures to require supplier investigations, and providing statistical training for annual product review personnel. The company also committed to submitting a written response to the Center for Veterinary Medicine within fifteen business days.