US generics maker Impax Laboratories says it has started addressing cGMP deviations observed by regulators at California manufacturing plant.
The comment follows an as yet unpublished warning letter from the US Food and Drug Administration (FDA) that detailed a number of violations at Impax’ plant in Hayward following an inspection late last year.
The quality problems related to sampling and in-process materials testing procedures, as well as to the review process for investigating production failure.
Impax, which conducted a voluntary recall in March of 2011 of five lots of Fenofibrate capsules 200mg, said that it has called in consultants to help it address the deviations, during which time it reduce production levels.
CEO Larry. Hsu said: "We don't anticipate that this manufacturing setback will delay our ongoing research and development activities. We expect to continue to develop our generic pipeline of 82 products and two brand products."
Wells Fargo Securities analyst Michael Tong agreed, telling Reuters the letter will not have a long-term impact on Impax’ ability to secure approvals for generic drugs but that it may be hurt in the short term by the slow down in production.
In other news it has been reported that Impax plans to invest around $52m (€35.6m) to expand production capacity at its manufacturing facility in Taiwan.
The Chunan plant, which was built for $24.5m and became fully operational just last year, currently produces around 450m tablets and, according to an SEC filing, is currently operating at 93 per cent capacity.
According to a report in the San Francisco Business Tribune Impax now intends to increase capacity to around 700m tablets and capsules each year.
Company spokesman Mark Donohue Sr told the paper that the investment is part of a project that will see the facility manufacturing as many as 1.5bn tablets a year by 2012.