Akzo Nobel warned by FDA over Mexican facility
pharmafile | December 20, 2011 | News story | Manufacturing and Production |Â Â Akza Nobel, manufacturingÂ
Akzo Nobel has been taken to task by the US FDA for manufacturing standards at one of its active pharmaceutical ingredient (API) facilities in Mexico.
A warning letter sent to the company in November and posted on the FDA website earlier this month, said the plant in Los Reyes La Paz showed significant deviations from current Good Manufacturing Practice for the manufacture of APIs during an inspection in July.
Moreover, the company’s response lacked sufficient corrective actions, said the agency, which has placed the plant under an import alert.
Specifically, Akzo Nobel failed to investigate and document contamination of batches of unidentified APIs produced at the plant. Black particles were observed by production personnel, who also reported hydraulic oil leaking from equipment, according to the letter.
“The inspection revealed that between August 2010 and August 2011, at least 10 maintenance requests were submitted as a result of oil leaks detected during manufacturing,” said the FDA.
“This trend of contamination of API with hydraulic oil indicates an inadequate equipment maintenance programme.”
The company also failed to have measures in place to prevent the use of quarantined API, with the FDA citing one case in which a contaminated lot was released and shipped to a distribution centre in the US.
Akzo Nobel has been instructed to provide an evaluation of its entire preventive maintenance programme for production equipment used at the plant.
Under the terms of the import alert, the FDA will continue to refuse admission into the US of all materials manufactured at the Mexican plant. It may also withhold approval of any new applications or supplements listing Akzo Nobel Chemicals in Mexico as an API manufacturer, it added.
Phil Taylor
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