FDA slaps Sichuan on API facility shortfalls

Sichuan Pharmaceuticals is in FDA woodshed. The agency sent a warning letter to the Chinese drugmaker, scolding it for manufacturing shortfalls at a plant in Pengzhou. During a June 2010 inspection of the facility, FDA representatives found that the plant had no procedures to make sure the active pharmaceutical ingredients and injectable drugs produced there were not contaminated. It's the second time this month that FDA has taken a foreign drugmaker to task for conditions at an overseas plant.

As the warning letter notes, the company made one API in a workshop adjacent to two other workshops, one that made another API and the other that produced an injectable. Sichuan had no procedures in place to make sure work in one workshop wasn't tainted by work in another. Plus, the company started making a new API in a facility that had been used for another product, without adequately cleaning and renovating it beforehand, the agency said. And then there's the fact that Sichuan hasn't registered every API in commercial distribution in the U.S. with the FDA as required by law.

Since the first inspection, the company's response to FDA hasn't been sufficient, the agency said. FDA now demands that Sichuan submit plans to decontaminate, renovate and reactivate the facility. And it ordered Sichuan to do the paperwork required to list all its U.S.-distributed APIs. If the company doesn't comply, FDA may bar products made at the Pengzhou facility from the U.S. market.

The Sichuan letter comes less than a week after FDA slammed an Indian API facility operated by Yag-Mag Labs with a warning letter--and put the company's products on import alert. The Hyderabad facility was cited for some more obvious manufacturing violations, including standing water, leaky pipes, and residue on processing equipment. And both letters come at a time when FDA is facing renewed scrutiny for its oversight of foreign drug and API plants.

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