FDA issued a warning letter to Jubilant HollisterStier’s Canadian facility, citing the sterile contract manufacturer for leaving a mold-linked environmental excursion uninvestigated for six months.
Inspectors visiting the plant in October and November 2025 found an adverse environmental trend that emerged in February 2025 didn’t trigger a company investigation until end of August. The FDA had already discussed the company’s insufficient oversight of environmental controls at a November 2024 meeting.
Environmental monitoring recovered 83 colony forming units from an operator’s neck during one sampling event — mold included. Jubilant told the FDA that former microbiology supervisors incorrectly advised personnel that non-product-related excursions didn’t require investigation.
The letter also cited smoke study failures. One study showed an operator extending their upper body over a conveyor while air moved toward exposed vials. A second operator placed their upper torso inside a cleanroom area and used gloved hands instead of sterile tools to remove vials. FDA concluded Jubilant’s quality unit “is not enabled to exercise proper authority and/or has insufficiently implemented its responsibilities.”
Jubilant extended its shutdown while verifying remediations that include improved gowning and cleanroom behavior. The FDA directed executive management to immediately assess global manufacturing operations for compliance.
On the same day, FDA published a warning letter to Huons, the South Korean manufacturer whose microbiology team leader used a knife to remove logbook pages and replaced them with backdated falsifications. Two sterile-fill warning letters in one session: one company sat on a mold trend for months, the other rewrote the record.
Huons has suspended U.S. drug production; Jubilant’s inspection window closed in November 2025.