Earlier this week, the company triggered a recall of one of its most popular anti-depressants, Seroxhat after the US Food and Drugs Agency found in October last year that the drug, which is manufactured in Cork, was contaminated by product from a waste tank.
In the letter to GlaxoSmithKline which prompted this week’s recall, the FDA also warned that GlaxoSmithKline’s inhouse quality tests in September and October 2011 had revealed “large peaks” of one contaminant and “small but detectable levels of at least 10 other contaminants” in their drugs.
“These unexpected peaks should have indicated to your firm that the tank had been contaminated with pharmaceutical waste.
“Instead, your laboratory personnel ignored these unexpected peaks and conducted no investigation into what gave rise to them. As a result, your firm did not notice the tank contamination until a third sample from the tank was tested in January 2012,” the FDA wrote.
According to the FDA, Glaxo defended its failure to “notice” the peak on the grounds it had “no reason to expect contamination”.
In a letter to the company dated March 18, the FDA official wrote: “Your response does not address why the analyst did not notice the numerous other detected contaminants in the chromatogram, nor did it address why a second reviewer did not notice the unexpected peaks in the chromatograms”.
GlaxoSmithKline Ireland has said it is only at the beginning of an investigation into the series of problems that led to it receiving its first ever letter of warning from the FDA.
The FDA inspection found the ingredients used to make Seroxhat were not being handled in a way that could be described as good manufacturing practice and had been contaminated.
The FDA said some batches of the drug were later shipped, and GSK did not notify its customers about the lapse.
When asked if they had remedied the queries raised by the FDA, Glaxo said they were still trying to take in the contents of the letter.
“We are still digesting the concerns raised, we only received the document last week and we are now focused on understanding their concerns. All corrections will take place once we fully understand their concerns. We’ll have to complete a site investigation.”
The FDA investigators also raised concern about the suitability of the equipment used to manufacture drugs at the Cork plant.
The company has until April 9 to respond to the letter, outlining in detail the actions it proposes to correct the issue.