FDA Cites Teva Supplier Celltrion in Follow-Up Inspection

August 10, 2018

The FDA cited a Celltrion plant based in Incheon City, South Korea, for violations observed during an inspection last month following a February warning letter to the facility.

Celltrion, which received a Form 483 for its violations, is in partnership with Teva Pharmaceuticals and supplies Teva’s migraine treatment fremanezumab. The PDUFA decision date is set for Sept. 16, so the FDA inspection doubled as a pre-approval inspection.

The agency found the facility did not properly manage situations in which glass vials broke during filling operations and threatened to contaminate product with glass shards. During one batch where two vials broke, the batch record stated, “debris and vials around the affected areas were removed in [the] filling room.” However, the record did not note any additional details, such as how many vials were removed.

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