Teva’s Irvine facility gets FDA green light
pharmafile | May 3, 2011 | News story | Manufacturing and Production |Â Â FDA, Teva, manufacturing complianceÂ
Teva Pharmaceutical Industries has said that an injectables facility in the USA, shut down last April after quality control problems, is now up to code and has restarted production.
The Israeli drugmaker was sent a warning letter by the FDA for failing to resolve Good Manufacturing Practice (GMP) problems uncovered by an agency inspection of its Irvine facility in July 2009.
The compliance problems related mainly to bacterial contamination issues arising during the production of propofol, a short-acting anaesthetic product, and other injectable drugs.
Teva has since stopped making the drug, and its exit from the propofol market, coupled with contamination problems at another key supplier Hospira, led to shortages of the anaesthetic across the USA.
The company is also experiencing shortages in a number of other injectable drugs sold in the US market, including amikacin, bleomycin, cisplatin, doxorubicin and leucovorin, according to the FDA’s website.
Closure of the Irvine facility shaved $230 million off its $16.1 billion sales last year, and the drugmaker has said that it would take the best part of 2011 to restore injectables production at the plant to pre-closure levels.
Teva was also warned in February of GMP problems at an oral solid dosage facility in Jerusalem that was inspected by the FDA in September 2010. The company says it has now submitted its formal response to the warning letter, detailing various corrective actions.
The FDA had cited failures in quality control procedures and reporting at the plant, which makes generic versions of Bristol-Myers Squibb’s Glucovance (glyburide and metformin) and Sanofi-Aventis’ sleeping disorder treatment Ambien (zolpidem).
Phil Taylor
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