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Regulatory Focus™ > News Articles > FDA Warns GSK’s UK Site for Contamination in API Manufacturing

FDA Warns GSK’s UK Site for Contamination in API Manufacturing

Posted 20 July 2016 | By Zachary Brennan 

FDA Warns GSK’s UK Site for Contamination in API Manufacturing

The US Food and Drug Administration (FDA) on Wednesday released a warning letter for GlaxoSmithKline’s Worthing, UK-based active pharmaceutical ingredient (API) manufacturing site.

The warning letter, dated 30 June, follows an eight-day inspection of the site from 2015 during which FDA uncovered GSK’s failure to prevent cross-contamination from dedicated penicillin manufacturing areas to non-dedicated areas.

FDA says it documented findings of penicillin in non-penicillin manufacturing areas about 69 times in 2012, 72 times in 2013, 30 times in 2014 and 16 times through 7 July 2015.

“Your facility and controls to prevent contamination of non-penicillin drugs with penicillin are wholly inadequate,” FDA said. “Contamination of non-beta-lactam drugs with beta-lactam drugs presents great risks to patient safety, including anaphylaxis and death. No safe level of penicillin contamination has been determined to be a tolerable risk. Severe allergenic response can occur in susceptible patients exposed to extremely low levels of penicillin and other beta-lactams. Due to the limitations of sampling and current analytical test methods, such levels are very difficult to detect.”

In addition, FDA said the company’s method for detecting penicillin in non-penicillin drugs manufactured at the facility is not validated to detect the different types of penicillin manufactured at the facility. In addition, GSK “could not locate the raw data for the method validation” and the company “has changed the method since the original validation.”

FDA also detected contamination in the site’s water systems.

Warning Letter

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