Akzo Nobel’s Mexican API plant all clear
pharmafile | June 19, 2012 | News story | Manufacturing and Production |Â Â API, Akzo Nobel, FDA, manufacturingÂ
Akzo Nobel has brought a manufacturing facility for active pharmaceutical ingredients in Mexico that failed an inspection last year back into compliance, according to the FDA.
The FDA sent Akzo Nobel a warning letter last November after uncovering significant deviations from current Good Manufacturing Practice for the manufacture of APIs during an inspection the prior July. The agency also introduced an import alert on material made there, refusing admission into the US.
Problems identified at the Los Reyes La Paz plant included contamination of API batches with unidentified black particles, and poorly-maintained equipment which was leaking hydraulic oil.
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.
A closeout letter from the FDA to the general manager of the plant, Ricardo Castaneda, suggests that the FDA is now satisfied with the steps taken by Akzo Nobel to remedy the situation.
“Based on our evaluation, it appears that you have addressed the violation(s) contained in this warning letter,” says the agency.
“Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections,” it adds.
The Los Reyes plant manufactures a range of materials used in manufacturing pharmaceuticals and other industrial goods, including organic peroxides, azo compounds, accelerators, polymerisation catalysts, acid chlorides and polymer additives.
Phil Taylor
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