Teva Pharmaceutical ($TEVA) has received a close-out letter from the FDA stating the generics giant has addressed issues raised after an inspection of its Jerusalem plant.
The close-out reflects remediation actions taken at the oral solid dosage plant following Teva's receipt of a warning letter in January. A June re-inspection by the FDA resulted in no adverse findings. "Based on our evaluation, it appears that you have addressed the violation(s) contained in this warning letter," the close-out letter says.
Earlier this year, Teva restarted production at its Irvine, CA, plant, following remediation efforts.
So far in 2011, with 450 warning letters issued across all FDA categories, only 26 have garnered close-out letters. The FDA says on its website that "a close-out letter may issue when, based on the FDA's evaluation, the firm has taken corrective action to address the violations contained in the Warning Letter."
Six of this year's close-out letters concern pharma products; 16 fall in the highest-closeout category: food.
- here's the story
- see the Close-out Letter
- here's Warning Letter 320-11-008