The US Food and Drug Administration (FDA) is yet to publish an official close-out letter following a re-inspection of the contract manufacturing facility in September 2013, but parent company Jubilant Life Sciences announced on the Bombay Stock Exchange (BSE) that it received communication from the agency and has addressed all issues raised in the February 2013 Warning Letter.
Amongst a number of GMP violations cited in the original letter, the FDA noted water running on the floor of the equipment wash room that was tracked into the dirty equipment staging room and into the pharmaceutical corridor leading to the sterile production hallway and the vial filling area.
“When there are open issues like the warning letter, the status is ‘unacceptable,’” Jubilant spokesperson Shannon Jordan told Outsourcing-Pharma.com. However, she continued, the FDA’s ‘acceptable’ status indicates that the site has been found to be compliant with cGMP.
“Most of the observations were related to the investigation and the inspection systems,” Jordan said.
“We have strengthened the quality oversight on the production floor and are performing a close follow-up on open investigations and corrective and preventive action (CAPA).” Furthermore, she continued, “We have implemented the AQL inspection after the 100% manual inspection of injectable products.”
We were also told Jubilant HollisterStier’s business had not been affected by the Warning Letter and no restrictions were placed on manufacturing. “The only impact was that FDA was not approving new products,” Jordan said.
Moreover, the letter did not hold back expansion at the site with the firm telling this publication in August it was increasing its ampoule production by nearly 200 percent in order to fulfil several new contracts. The new filling line (the ‘Rota’) is “now fully operational,” Jordan confirmed when asked yesterday.
The Quebec plant was not the firm’s only facility to be hit with an FDA warning last year. The Spokane, Washington State manufacturing facility – which generated around 7% of total contracting revenue in the first half 2014 - received a letter to which Jubilant said it would respond by December 12.
When questioned on the progress of the Spokane plant, Jordan told us: “We have completed an extensive review of our systems and are in the process of implementing a plan.”