UPDATED: Teva’s struggling sterile plant hit with FDA warning letter

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The regulatory quagmire has deepened for the Teva Pharmaceutical sterile injectables plant in Hungary which the FDA banned this year over slipshod manufacturing standards. The FDA has now issued the plant a warning letter.

In an SEC filing on Tuesday, Israeli-based Teva acknowledged receiving the warning letter the previous Friday, and for the first time gave some indication of the problem areas. It said the FDA “cited deficiencies in manufacturing operations and laboratory controls, and in the Company’s data integrity program.”

In an emailed statement today, Teva said it “has been using a systems-based approach with respect to our remediation efforts,” addressing both the FDA concerns and the underlying causes. “As a matter of practice, Teva manufactures according to the highest quality and compliance standards.”

The company also said it is working to resupply “critical and priority products as quickly as possible,” by bringing in products from other Teva manufacturing sites and finding other suppliers for products in short supply or out of stock.

The warning letter follows a series of other actions by the FDA, which first issued a Form 483 following a two-week inspection in January at the Godollo plant, a relatively new facility which the company opened in 2012 to expand its injected drug capacity. Teva suspended production to deal with the citations but the FDA in May put the plant on its import alert list, banning all but two drugs–the cancer treatment bleomycin and antibiotic amikacin, which were exempted to avoid shortages. Teva has been recalling from the market its other drugs produced at the facility.

The regulatory issues come when Teva has a lot on its plate. It is in the process of assimilating a huge portfolio of products, plants and employees it got in its $40.5 billion buyout of Allergan’s generics business, while selling off those parts of the business required by regulators to preserve competitive markets.

But Teva has suggested it may not be done with acquisitions to solidify its place as the largest maker of generic drugs, while also looking at moves in the branded market. Earlier this week, a Teva spokesperson said the company would consider opportunities in biosimilars, suggesting to some that Teva might look at buying South Korea’s Celltrion. Celltrion is trying to sell part of its business and the two have a relationship.

CEO Erez Vigodman has said the biosimilars are part of the company’s growth strategy but also said it will be on the hunt for “attractive specialty assets, or branded drug assets or pipeline assets” that fit in with the therapeutic areas it’s already tackling.

– read the filing

thanks to: FiercePharma
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