FDA Wants Big Changes From GSK Subsidiary on Penicillin Contamination

The FDA is pressing a GlaxoSmithKline subsidiary to make a hard choice about operations at a U.K. plant: either decontaminate the whole facility to address repeated problems with penicillin contamination or else restrict production to penicillin.

The agency asked SmithKline Beecham “to commit” to one of those options at its Worthing plant after penicillin was found in non-penicillin production areas of the plant 187 times between 2012 and 2015, according to a warning letter.

FDA inspectors chalked this up to “significant deviations” in the company’s procedures to prevent cross-contamination, investigate critical deviations and implement corrective and preventive actions for active pharmaceutical ingredients.