Spanish API supplier Ercros warned by FDA
pharmafile | July 17, 2012 | News story | Manufacturing and Production |Â Â Ercros, FDA, GMPÂ
Spanish chemical supplier Ercros SA has been sent a warning letter from the FDA after an inspection picked up a series of Good Manufacturing Practice violations.
An FDA team visited the company’s active pharmaceutical ingredient (API) manufacturing facility in Aranjuez, Madrid, in July 2011 and raised a number of issues, including failures in the validation of its water purification systems which could have allowed contamination of ingredients.
Ercros had submitted a response to the FDA last August but this was deemed inadequate by the agency, prompting the 20 June warning letter. The company’s pharmaceutical operations focus on erythromycin derivatives, phosphomycin and fusidic acid.
In addition to an inadequate attempt to validate the water purification system, Ercros failed to properly document endotoxin tests used to ensure water used in production is within specifications, which was a repeat offence from an earlier inspection in 2002.
Other shortcomings mentioned in the letter include a failure to maintain buildings and equipment used in the manufacture of intermediates. The FDA gave as examples the accumulation of dirt on top of tanks, a white residue left in the bottom of a tank and evidence of pests such as birds and spiders.
The company also came in for criticism for not investigating critical deviations or a failure of a batch to meet its specifications or quality standards, such as excursions of temperature and relative humidity in its stability chambers and sample retention room. It also failed to investigate incorrect labelling of laboratory samples that led to laboratory errors.
Ercros supplies basic chemicals, plastics, chemical intermediates and pharmaceutical ingredients, and posted sales of €686 million in 2011.
The company operates 15 production facilities across Spain and employs around 2,000 workers, with its pharmaceutical operations centred at the Aranjuez facility.
The company said in its 2011 financial report that it has been considering downsizing its pharma workforce as a result of ‘slow growth conditions’ in the marketplace.
Phil Taylor
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