PROMEPLAMay 16, 2018

FDA 483 - PROMEPLA - May 16, 2018

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Record Details

An FDA inspection of PROMEPLA in Monaco identified a single observation related to inadequate documentation of corrective and preventive action (CAPA) activities. Specifically, the firm failed to establish sufficient acceptance criteria to verify the effectiveness of corrective actions. This indicates a deficiency in the firm's quality system regarding CAPA procedures.

Company: PROMEPLA
Inspection Date: May 16, 2018
Product Type: Other
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
Person: Ronald Ifraimov (investigator)

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ID · d4059a53-8e42-41c1-b906-60fd3fdcc7ef