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Ll "g - Food and Drug Administration - fda

Ll "g - Food and Drug Administration - fda 2025

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The document is an FDA inspection report for Integra LifeSciences Corp, detailing observations made during inspections from July 22 to August 25, 2011. It highlights multiple compliance issues related to the manufacturing of medical devices, including inadequate environmental controls, unvalidated processes, delayed investigations of complaints, and failure to submit Medical Device Reports (MDRs) in a timely manner. The report emphasizes the firm's responsibility for internal audits and corrective actions to address identified violations.

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