Jubilant Pharmova Limited said Jubilant HollisterStier General Partnership received a Warning Letter from the USFDA for its sterile contract manufacturing facility in Kirkland, Canada.
The USFDA issued the Warning Letter after completing its review of the Establishment Inspection Report for an inspection conducted at the 16751 Trans-Canada Highway facility from October 20 to November 3, 2025. The disclosure regarding this regulatory development was made to the stock exchanges on May 29, 2026.
Jubilant Pharmova had previously updated the exchanges on this matter on February 13, 2026, and November 4, 2025. JHSGP has initiated corrective and preventive actions and is engaging with the USFDA to address the observations raised during the inspection.
Current operations at the Kirkland facility are continuing under enhanced controls and oversight while remediation efforts remain under way, Jubilant Pharmova said.
The Kirkland facility provides contract manufacturing services for sterile products, including liquid and lyophilized injectables, ophthalmic solutions, and sterile ointments. These services are part of Jubilant Pharmova's CDMO business and cater to pharmaceutical companies across regulated markets including the United States and Europe.
JHSGP is jointly owned by subsidiaries of Jubilant Pharma Limited, a wholly owned subsidiary of Jubilant Pharmova Limited. The partnership contributes to Jubilant Pharmova's contract manufacturing capabilities for sterile injectables and ophthalmic products.
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