FDA warns Teva on Jerusalem plant shortfalls

Teva Pharmaceutical Industries was slapped with another FDA warning letter, this time on a Jerusalem plant that makes oral drugs. However, although FDA's issues may interfere with new applications on drugs made at that plant, it won't affect Teva's prospective copy of the Eli Lilly antipsychotic blockbuster Zyprexa, because that drug is made elsewhere.

The letter comes after a September visit from FDA inspectors, who found "significant violations" of manufacturing standards in the plant's laboratory reporting and systems. The issues could lead to "adulterated" products, the warning letter says, and Teva's October response to the agency's worries "lacks sufficient corrective actions."

The warning-letter boilerplate points out that, until Teva fixes the problems to FDA's satisfaction, the agency can withhold approval from pending apps for drugs made at the plant and can keep that plant from exporting its products into the U.S.

Citi analyst John Boris told Israel's Globes news service that he doesn't expect the manufacturing issues to "materially affect production or shipment" from that plant, whose output accounts for less than 3 percent of Teva's global sales. The two drugs cited in FDA's report are the generic version of the diabetes drug Glucovance and Teva's copycat of the sleep drug Ambien.

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