483
Pillar Biosciences Inc.Pillar Biosciences Inc. – FDA 483, Sep 16, 2025
Record Details
An FDA inspection of Pillar Biosciences Inc. in Natick, MA, revealed significant deficiencies in their corrective and preventive action (CAPA) procedures. The firm failed to consistently meet CAPA timeline requirements, adequately document extensions, and ensure consistency between its CAPA-related standard operating procedures. These issues indicate a breakdown in the firm's quality system regarding corrective and preventive actions.
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ID · f5236b8a-243d-4904-8646-ff97513a53eb
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