Jubilant HollisterStier received a warning letter over problems that the FDA said necessitate an immediate and comprehensive assessment of the contract manufacturing organization’s global operations.
The FDA has hit Jubilant HollisterStier with a warning letter after inspectors found sterility failings at the contract manufacturer’s Canadian plant.
FDA inspectors found Jubilant failed to investigate “mold recoveries on personnel” until months after its environmental monitoring activities revealed an adverse trend. The manufacturer found excessively high microbial counts on cleanroom personnel on multiple occasions, including a time when it recovered 83 colony forming units from sampling an operator’s neck. The units included mold.
The FDA discussed Jubilant’s insufficient oversight of environmental control at a meeting in November 2024. Yet an adverse environmental trend that began in February 2025 didn’t spark a company investigation until the end of August, inspectors found when they visited the facility in October and November.
Jubilant blamed the lag between trend detection and investigation on former microbiology supervisors who incorrectly advised personnel that non-product-related excursions didn’t require investigation, the company told the FDA. Jubilant has extended its shutdown until it verifies remediations, including improved gowning, cleanroom behavior and environmental monitoring, according to the FDA.
The agency acknowledged Jubilant’s efforts to address the problems identified in the inspection. However, the FDA said the response failed to adequately address the responsibility of the company’s quality unit to ensure procedures are followed and environmental monitoring excursions are investigated.
FDA officials concluded that Jubilant’s quality unit “is not enabled to exercise proper authority and/or has insufficiently implemented its responsibilities.” The agency advised Jubilant’s executive management to immediately and comprehensively assess the company’s global manufacturing operations to ensure that its systems, processes and products conform to FDA requirements.
The recommendation reflects the belated investigation, plus inadequacies in smoke studies the company ran to visualize airflow. Inspectors noted a smoke study in which an operator extended their upper body over a conveyor. Air moved across the operator and toward exposed vials. Another operator placed their upper torso inside a cleanroom area and used gloved hands, rather than sterile tools, to remove vials.
The FDA published its assessment of Jubilant’s Canadian plant on the day it released another warning letter about smoke studies. Huons received the other letter after FDA inspectors found fault with its response to smoke studies performed at a plant in South Korea. The smoke studies showed multiple instances of turbulent airflow in critical areas of an ampoule filling line.
FDA inspectors’ concerns about Huons’ smoke studies were part of a wider set of issues uncovered when they visited the plant in November. Management told the FDA about breaches in data integrity, including a team leader who ordered staff to discard bioburden plates with significant growth and manipulate camera timestamps to create backdated documentation.
Huons’ microbiology team leader removed completed pages from the logbook with a knife and replaced them with pages manipulated to look like the originals. The leader instructed an analyst to backdate and omit testing information related to bioburden samples. Huons told the FDA that it no longer employs the personnel involved in data manipulation. The company suspended drug production for the U.S. market.
