Warning cites API cross-contamination

Cross-contamination has tripped up API maker ZaCh Systems in France. The company was cited in an October warning letter for lacking procedures necessary to prevent cross-contamination. Beyond the contamination, however, the FDA cited the company for its initial inaction and then slow follow-up after the contamination had been discovered in a drug ingredient that had been released for distribution.

The warning letter says that ZaCh received a complaint regarding metallic contamination in lots of the anti-diabetic agent, Pioglitazone HCl. When the company investigated, it also found cross-contamination involving three different APIs and one intermediate product. Metallic particles and residual solvent were also found inside the threads of a screw located inside a sealed box.

ZaCh reported that incorrect equipment re-assembly during maintenance in 2007 led to the contamination.

The regulator notes in the letter that the extent of the contamination remains unknown. As of late September 2009, ZaCh had tested "a limited number" of batches manufactured between April 2007 (when the maintenance was done) and March 2008, when the metallic material complaint was received. "We remain concerned that while your investigation remains open, your customers may still be manufacturing products with the affected API lots," the letter says.

- here's the warning letter


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