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Warning letter issued to GlaxoSmithKline over contamination at a Penicillin Plant in UK

US FDA has issued a warning letter to GlaxoSmithKline over quality control problems observed at Penicillin manufacturing facility located in Worthing in the United Kingdom. GlaxoSmithKline is therefore recalling a “small” number of batches of its Bactroban antibiotic from the plant due to contamination observed by the US regulators.

The FDA issued the warning letter as a follow-up to a July 2015 inspection of the facility where the inspectors found “significant deviations” from good manufacturing practices. In its letter, the agency complained that Glaxo failed to have appropriate procedures in place to prevent cross-contamination from an area dedicated to penicillin manufacturing to other manufacturing areas. FDA inspectors found penicillin in other areas 69 times in 2012, 72 times in 2013, 30 times in 2014, and 16 times through July 2015. According to FDA’s letter, contamination of other types of drugs with antibiotics 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 antibiotics.

The letter also said that Glaxo was urged to switch the facility to produce only penicillin or fully decontaminate the facility. This not the first time, by the way, this facility has been an issue. The FDA issued a warning letter to the drug maker in 2011 about contamination concerns at the same facility.



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