Jubilant HollisterStier, a CDMO unit of India’s Jubilant Pharmova, earned an FDA warning letter after inspectors found its Montreal production plant lacked appropriate quality control systems.
The facility, which focuses on liquid sterile products including injectables, was issued the rebuke following an inspection conducted between late October and early November last year. The facility was issued a Form 483 in late November.
The May 28 warning letter posted to the FDA website outlined two significant violations for failing to follow regulatory procedures to prevent microbiological contamination and not thoroughly investigating discrepancies or failures of a batch to meet specifications.
Inspectors found design deficiencies that posed significant hazards to drug product sterility, as well as multiple inadequacies in its smoke studies.
“During a smoke study simulating an aseptic intervention of the (redacted) line, an operator extended their upper body over the conveyor,” the FDA said. “Smoke studies demonstrated air movement across the operator’s body and flowing toward exposed vials.”
The FDA also noted inspections conducted in February 2023 and June 2024 also uncovered deficient aseptic process simulations, and the agency concluded Jubilant “failed to adequately correct this deficiency.”
The warning letter also cited Jubilant for not taking a deep dive into unexplained discrepancies or failures of a batch or any of its components to meet specifications, whether or not the batch has already been distributed.
The agency said the company recovered 83 colony-forming units, including mold, from sampling an operator’s neck in the ISO 7 area; however, Jubilant did not initiate a deviation investigation.
“You continued to not conduct investigations of environmental monitoring action level excursions in 'non-product related' areas, such as gowning rooms and corridors,” the FDA said. “Your failure to promptly investigate these excursions may allow microbiological contamination hazards to persist and worsen in your classified areas.”
The company sank $76 million into expanding the Montreal facility in 2022 in a move to double the facility’s production capacity as part of Jubilant’s efforts to ramp up its sterile injectables output in the wake of the COVID-19 pandemic.
That expansion was spurred by a contract from the U.S. government worth $146.6 million to prepare for any future pandemics.