Wockhardt UK sterile site hit with FDA warning
pharmafile | November 29, 2016 | News story | Manufacturing and Production | FDA, Wockhardt, Wrexham
Mumbai-based pharmaceutical and biotechnology firm Wockhardt has been hit with more manufacturing woes as the FDA issued a warning letter against the company concerning the processes at its facility in Wrexham, UK.
According to the administration, the facility, which specialises in sterile injectable products, has failed to put in place any satisfactory protocols to prevent contamination of drug products during the manufacturing process. Staff were also frequently observed causing cross contamination in the ISO 5 sterile area within disinfecting their hands. The FDA made the accusations in a formal letter on 16 November, threatening to ban US approvals from products made at the plant.
The MHRA and FDA-approved UK facility operates as CP Pharmaceuticals, a subsidiary of Wockkhardt, and cites a successful visit from the FDA in August 2013; the company even had plans to add 50 jobs to the site through a $12 million sterile manufacturing expansion, a move which the company will now likely backtrack on. In India, Wockhardt has been the target of FDA scrutiny with three of its plants banned by the FDA for operational transgressions over the past three years.
In order to rectify the issues outlined in the letter, Wockhardt have been advised to consult an aseptic processing specialist due to “the nature of the violations we identified at your firm and because you failed to correct repeat violations”, according to the FDA’s statement; Wockhardt itself assured its investors it is taking action to correct these cited problems:
“Currently, there is no business being conducted from CP Pharmaceuticals to the US market. CP Pharmaceuticals has already initiated required steps to address the concerns raised by the US FDA and will be responding to the agency within the prescribed time.”
Matt Fellows
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