The US Food and Drug Administration (FDA) inspected the Currabinny, Cork active pharmaceutical ingredient facility in October 2013, and identified a number of deviations from current good manufacturing practice (cGMP).
The Letter, received March 18, noted the firm had failed to fully investigate critical deviations after equipment used to make batches of APIs were found to be “contaminated with material from [its] pharmaceutical waste tank, which contained APIs, intermediates, and solvents.”
Whilst GSK was aware of the contamination risk in January 2012 and completed risk assessments to determine the impact on the quality of its product, some potentially contaminated batches were still distributed.
A statement sent to in-Pharmatechnolgist.com from a GSK spokesman said: "We are currently reviewing the content of the FDA letter to assess the concerns raised. In the meantime, we have proposed a Class 3 recall – that is a recall from wholesalers - of certain batches of Paxil/Seroxat containing the active ingredient Paroxetine supplied by the Cork site, that are within the scope of the Warning Letter.
Paxil is a selective serotonin re-uptake inhibitor used to treat amongst other things major depression, obsessive-compulsive disorder, panic disorder, and social anxiety. The drug has been off-patent since 2003.
"A medical assessment concluded that that there is no risk of harm to patients by taking Paxil/Seroxat manufactured from the implicated batches of paroxetine API. However GSK has acknowledged some procedural issues raised by the FDA about the testing done to the support the release of product," GSK added.
The Letter further questioned GSK’s view on quality after the FDA’s investigator was informed the firm did not wish to “escalate” the deviation by informing customers.
“We are concerned that your firm does not consider the entry of pharmaceutical waste streams into your manufacturing process a significant deviation with a potential quality impact,” the FDA noted.
The agency also pulled GSK up on its failure to investigate and document out-of-specification results, and the failure to demonstrate that its manufacturing process could reproducibly manufacture an API meeting its predetermined quality attributes.
“Demonstrating suitability of equipment used in the manufacturing process is a fundamental element of establishing the state of control of your process. Because of these equipment suitability deficiencies, we are concerned that your firm has not adequately demonstrated an ability to consistently and reproducibly manufacture [the product].”
According to GSK’s website, the firm has been manufacturing APIs from the site since 1975 and is described as “a strategic global new product introduction site within GSK’s manufacturing network.”