JHS Expands Sterile Manufacturing at Recently Warned Plant
The contract manufacturing organization (CMO) is increasing its ampoule production capacity at the plant by nearly 200 percent as part of a first phase expansion of its sterile manufacturing services offering.
In a statement the company said a significant part of the expansion would be dedicated for new customer products and JHS’ CEO, Marcelo Morales, added: “We have been fortunate to secure several new contracts that will utilize our expanded capacity starting this year.”
The company is adding a new ampoule filling line utilizing a rigid barrier system which is scheduled to be operational early next month.
GMP Violations
In February this year the Kirkland plant was hit by a warning letter from the US Food and Drug Administration (FDA) who cited a number of violations, including failure to confirm to final specifications for the drug product, and failure to establish criteria for sampling and testing.
This came as a result of an inspection in 2012 that noted “water running on the floor of the equipment wash room that was tracked into the dirty equipment staging room and further, into the pharmaceutical corridor leading to the sterile production hallway, the line, and the vial filling area.”
Outsourcing-Pharma.com contacted both JHS and its parent body, India-headquartered Jubilant Life Sciences, by phone and email but comments regarding both the new expansion and the facility’s approach to quality were not available at the time of going to press.
However, a statement from Jubilant Life Science in February said manufacturing at the Kirkland had not been affected by the warning letter and added “JHS is committed to implementing the necessary corrective actions required to address the FDA concerns, and will work closely with the FDA to bring resolution to this matter.”
