483
Lonza Bend Inc.FDA 483 - Lonza Bend Inc. - May 19, 2026
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Record Details
Lonza Bend Inc. in Bend, OR, was cited for failing to thoroughly review unexplained discrepancies and trend deviations to prevent recurrence. The inspection revealed repeat issues related to gasket failures, data loss and storage discrepancies, and missing manufacturing documentation, indicating significant quality system deficiencies.
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ID · 3be12913-2ef2-4162-a594-fc55b54c498a