GlaxoSmithKline is recalling a “small” number of batches of its Bactroban antibiotic following a harsh rebuke from US regulators about contamination at a key plant. The move comes after the US Food and Drug Administration sent a stern warning letter late last month to the drug maker about a host of quality-control problems at the facility, which is located in Worthing in the United Kingdom.
The FDA issued its missive as a follow-up to a July 2015 inspection of the facility and found what it called “significant deviations” from good manufacturing practices, according to the June 30 letter, which was posted on the agency web site yesterday. The FDA, moreover, also noted that the drug maker provided an inadequate response, despite having halted production of the antibiotic and recalling product from wholesalers last year.
The letter is the latest attempt by the FDA to bolster the viability of the pharmaceutical supply chain amid a rash of quality-control gaffes. The agency has been attempting to crack down on manufacturers and ingredients suppliers — particularly in India and China — in response to various episodes that led to product recalls and import bans. Many of these efforts, however, have targeted smaller players.
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This simply didn’t happen in the days of strict cGMPs. Back then penicillin or any other antibiotic HAD to be made at a dedicated facility, hence cross contamination was never an issue before regulators began loosening the regulations in response to claims from pharma that dedicated antibiotic plants would make manufacturing cost ineffective.