GlaxoSmithKline is recalling a “small” number of batches of its Bactroban penicillin 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 Tuesday 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 July 19 letter. The agency, moreover, also noted that the drug maker provided an inadequate response, despite having halted production of the penicillin 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.
