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Jubilant Unit Receives Warning Letter

Spokane CMO facility cited by agency

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

The Spokane, WA facility of Jubilant Hollister-Stier (JHS), a subsidiary of Jubliant Life Sciences, has received a Warning Letter from the FDA related to an April 2013 audit. The parent company of JHS announced the issuance of the letter, which was posted to the FDA’s Warning Letters page this morning. At the time of the audit, the FDA identified several concerns related to the preparation of equipment and resumption of production following a manufacturing shut-down event, as well as conc...

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