- The Food and Drug Administration declared the active pharmaceutical ingredients produced in GlaxoSmithKline's Worthing, U.K. plant were adulterated due to unchecked penicillin and microbe contamination, according to a letter released this week.
- In a July 2015 inspection of the Worthing plant, the regulator identified nearly 120 incidents of penicillin contamination in non-penicillin production areas since 2012, and poor procedures for addressing 25 cases of microbial contamination in samples between 2014 and 2015.
- The letter marks the second time the facility has been warned of improper quality control procedures. In 2011, the FDA warned the same plant of inadequate sterilization, personnel gown monitoring and laboratory control procedures.
After the July 2015 inspection, GlaxoSmithKline closed down a portion of the plant to address the issues and recalled various shipments of Bactroban, a skin infection antibiotic.
But the FDA saw the measures as inadequate, and demanded the plant (1) provide a risk assessment of the manufacturing process to control for microbial contamination, and (2) either dedicate the plant solely to penicillin production or (b) provide a full decontamination plan.
The plant has been closed while the additional safety procedures are conducted, and about 20 batches of Bactroban were recalled, STAT news reports.
The Worthing plant is one of GSK's 10 manufacturing and supply chain sites in the U.K, and employs roughly 1,000 people. The plant is also one of two U.K. plants that specialize in antibiotic manufacture, according to the company's 2016 industrial placement map.