Sanofi plant in France under FDA scrutiny

pharmafile | August 3, 2010 | News story | Manufacturing and Production |  Sanofi Pasteur, manufacturing compliance 

Sanofi-Aventis failed to follow proper quality control procedures at a vaccine manufacturing plant in France, according to the US Food and Drug Administration.

A letter posted on the FDA’s website indicates that several deviations from Good Manufacturing Practice (GMP) were observed at the plant in Marcy l’Etoile, operated by the company’s Sanofi Pasteur vaccine subsidiary, when inspectors visited in March and April 2010.

Vaccines affected by the GMP violations included Sanofi Pasteur’s hepatitis B product Act HIB, Typhim Vi for typhoid, the inactivated polio vaccine Ipol and two shots for rabies (Imogan and Imovax).

Top of the list of transgressions identified by the FDA was a failure to thoroughly investigate batch failures – a criticism that has been occurring with increasing frequency in FDA letters of late – including out-of-specification pyrogen results for Typhim Vi batches.

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Sanofi Pasteur also failed to notify the FDA of product deviations “for lots of bulk and final drug product that represent marketed product and have failed stability at various time points”, according to the letter. Other problems included a failure to follow microbial contamination control procedures.

Sanofi said it had either addressed the problems described by the FDA or was in the process of setting them right, and it does not expect any interruption in product supply as a result of the FDA action.

Other FDA actions

Meanwhile, the FDA has pulled up a number of other companies’ manufacturing facilities in recent days.

US company Aveva Drug Delivery Systems has been sent an FDA warning letter for GMP violations at its Florida facility related to manufacturing of its transdermal patches. These include a failure to deal with out-of-specification potency testing results affecting its clonidine patch product.

Abbott Laboratories has been warned by the FDA for not having acceptable investigation procedures in place for handling customer complaints. The agency cites as evidence complaints received about product made at Abbott’s Barceloneta facility in Puerto Rico, in particular two instances in which a tablet was passed unabsorbed in a stool.

An inspection of Cardinal Health‘s Fort Lauderdale facility in Florida, USA, revealed a number of GMP violations, including a failure to document, investigate and correct problems with analytical equipment.

Phil Taylor

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