FDAnews Drug Daily Bulletin
Pharmaceuticals / Inspections and Audits

Canadian Manufacturer Draws Warning for Sterility Issues

Sept. 13, 2018
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The FDA hit Montreal-based drugmaker Lernapharm (Loris) with a warning letter over serious sterility violations and air filtration problems that were not resolved after a December 2017 inspection.

The investigators found that the facility reprocessed multiple batches of supposedly sterile product that failed to meet quality specifications, reprocessing one product lot after five test strips detected microbial growth.

The inspectors also noted the firm lacked proper air filtration systems in its production areas. The areas in question had insufficient control and air classification, conditions the agency found inadequate for protecting the drugs and container-closure systems.

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