FDA 483 - JCB Laboratories LLC - February 27, 2013

An FDA inspection conducted from February 12-27, 2013, at JCB Labs LLC, a producer of sterile drug products located in Wichita, KS, identified several significant manufacturing deficiencies. The inspection, documented in an FDA 483, highlighted critical issues concerning quality control and aseptic processing. Specifically, the firm lacked scientifically sound test procedures to ensure the identity, strength, quality, and purity of drug products like repackaged Propoven (propofol) 1%. A contract laboratory's Certificate of Analysis even indicated that testing methods were not validated. Procedures to prevent microbiological contamination were also deemed inadequate, as environmental monitoring was not conducted with each production run for Propoven, a formulation known to promote microbial growth. Furthermore, JCB Labs LLC was cited for failing to record and justify deviations from written production and process control procedures. The actual repackaging process for Propoven deviated from established batch records, including unrecorded venting of vials to the pharmacy atmosphere without assessing its impact on product quality. Finally, the company had no written program to assess the stability characteristics of drug products, setting a 45-day Beyond Use Date for repackaged Propoven based on an unvalidated analytical method. These observations indicate a need for comprehensive corrective actions to align the firm's operations with good manufacturing practices for sterile drug production.