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Pharmaceuticals / Inspections and Audits

Canadian Drug Facility Cited for Contamination Risks

Dec. 11, 2018

Contract drug manufacturer Jubilant HollisterStier drew a Form 483 after the FDA observed contamination risks at the firm’s Kirkland, Quebec facility.

In an inspection carried out May 24 to June 1, the investigator noted that the facility failed to follow procedures designed to prevent microbiological contamination of its sterile drug products.

The inspector observed two operators holding tweezers below their hands and/or a vial tool, blocking air from a HEPA filter. The tweezers, the agency noted, were used in numerous interventions with vials on one of the firm’s fill lines.

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