The QMN Weekly Bulletin
Pharmaceuticals / Regulatory Affairs / GMPs / Inspections and Audits

GSK Warned for GMP Shortfalls, Wholesaler Recall Proposed

April 4, 2014

The FDA has warned GlaxoSmithKline subsidiary SmithKline Beecham over its failure to adequately address contamination of drug ingredients manufactured at its Currabinny, Carrigaline, Cork, Ireland, plant.

During an October 2013 inspection, FDA investigators found that the company had produced batches of API tainted by pharmaceutical waste from the plant’s waste tank.
The investigator noted the company was slow to pick up on the contamination, despite testing that revealed the presence of contaminants, because the lab personnel did not anticipate the contaminants that were found.

Additionally, GSK’s standard operating procedure requires communication to sites receiving any faulty product if deviations would have a potential quality impact on a product. According to the March 18 warning letter released by the FDA April 1, the drugmaker chose not to alert anyone receiving the products with the tainted components.

“We are currently reviewing the content of the FDA letter to assess the concerns raised,” Kalpesh Joshi, a GSK spokesman, said.

In the meantime, the company has proposed a Class 3 recall from wholesalers of certain batches of Paxil (paroxetine hydrochloride) and Seroxat (paroxetine), whose active ingredient was supplied by the Cork plant.

Joshi added that the company performed a medical assessment and concluded there is no risk to patients taking Paxil or Seroxat manufactured from the implicated batches of paroxetine.

While GSK addresses the quality problems, FDA warned that it may stop imports of any products made at the Irish plant and it may withhold approval of submissions for products that rely on the troubled plant.

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