The Israeli drug manufacturer announced the warning letter in a US Securities and Exchange Commission (SEC) last week, explaining that the agency had raised concerns about production and laboratory activities at the site.
“The letter cites deficiencies in manufacturing operations and laboratory controls, and in the Company’s data integrity program. Teva has undertaken corrective actions to address both the specific concerns raised by investigators as well as the underlying causes of those concerns. Communication with the FDA is ongoing.”
Teva said it will respond to the Warning Letter on November 4.
Background
The Godollo facility has ceased production of all but two of the 200 drugs previously made at the site in January following a US Food and Drug Administration (FDA) inspection that uncovered a number of problems.
On May 27 the US FDA issued an import alert on almost all sterile injectable drugs made at the facility citing unspecified good manufacturing practices (GMP) problems.
Until August Teva had been permitted to ship two drugs made at the facility – the antibiotic Amikacin sulfate and the cancer medication bleomycin – to the US.
Previously both products were identified as being in short supply in the US. However, on August 9, Amikacin was removed from the list prompting Teva to withdraw the product.
In September the firm told us it was “months away” from restarting production at the site.