FDA 483 - Grimm Scientific Industries - June 16, 2023
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Grimm Scientific Industries in Marietta, OH, underwent an FDA inspection from June 13-16, 2023, which identified significant deficiencies in its corrective and preventive action (CAPA) procedures. The firm's CAPA subsystem allowed unauthorized access and modification of records, lacked adequate documentation for validation testing, and failed to generate CAPAs for complaints. These issues indicate a critical breakdown in the firm's quality management system regarding corrective and preventive actions.
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ID · 96b6dc17-e263-49fa-9bb0-5d9f7d8cfe68