JCB Labs Gets Warning Letter for Adulterated Propofol

July 25, 2014

Compounding pharmacy JCB Laboratories has been hit with an FDA warning letter for failing to properly package and store vials of the powerful anesthetic Propoven.

The company received the July 7 citation following a Feb. 12-27, 2013, inspection of its Wichita, Kan., facility, and reports of adverse events related to its manufacture of 10 mL injections of Propoven (propofol 1 percent).

The FDA chided JCB Labs for venting its source vial of Propoven to the pharmacy atmosphere without determining what effects that exposure might have on the finished drug product. Propoven becomes unstable when exposed to oxygen. The company also failed to store Propoven in tight containers in an inert atmosphere, the letter said.

Investigators discovered that the company’s standard operating procedure for cleaning and maintaining clean-room facilities failed to require the use of sterile disinfectants, cleaning pads, towels or sporicidal agents. This situation “could lead to contamination of the products, putting patients at risk,” the agency said.

The FDA recommended the company undertake a comprehensive assessment of its operations, including facility design, procedures, personnel, processes, materials and systems. The assessment should focus specifically on the labs’ aseptic processing systems and design, regulators said, and should be done with the help of an outside expert consultant.

The agency gave JCB Labs until July 28 to respond to the warning letter. President Brian Williamson said that his facility is committed to compliance as a 503B outsourcing facility and expects to close out the warning letter.

JCB Labs is registered with the FDA as a compounding pharmacy. Earlier this month, the agency released two interim guidances establishing a GMP and inspection framework for compounders that choose to register.

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