FDAnews Drug Daily Bulletin
Pharmaceuticals / Inspections and Audits

Oregon API Manufacturer Cited for Laser Drill Operations

Oct. 16, 2018
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The FDA called out Bend Research for failing to adequately review discrepancies at its API facility in Bend, Oregon.

In a July 23-27 investigation, the agency noted that the firm failed to properly document all manufacturing operation discrepancies, many of which involved its laser drill equipment.

For example, one laser drill’s failure alarm rang multiple times, but only four instances were noted in the production record and no deviation investigation was opened to determine the root cause.

The firm also had no in-process control sampling associated with its laser drill tablet inspections.

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