FDA EIR - WuXi Advanced Therapies - April 17, 2015

WuXi AppTec, Inc. in Philadelphia, PA, underwent a GMP inspection by the FDA from April 13 to April 17, 2015. The inspection, conducted under Compliance Program 7356.002 M for Licensed Biological Therapeutic Drug Products, focused on the company's operations as a contract testing laboratory for biotechnology drug and device products, as well as its cell therapy manufacturing. The inspection revealed several significant deficiencies in the firm's quality and laboratory systems.

The FDA issued a Form 483 with three main observations: the quality control unit's responsibilities and procedures were not fully documented or followed; deviations from written test procedures lacked justification; and laboratory records were incomplete, missing crucial data for assuring compliance with specifications. Additionally, verbal discussions highlighted recurring issues from a 2012 inspection regarding inadequate equipment calibration and maintenance program review. Other verbally noted concerns included undocumented storage of "On-Hold" samples, insufficient quality assurance review of Standard Operating Procedures (SOPs), and the absence of analyst signatures and dates on some laboratory records.

Management acknowledged the findings and committed to implementing corrective actions, stating that a written response detailing these corrections would be submitted to the District office within 15 days.