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Remediation Project: Ohio

Following a history of compliance problems marked by Warning Letters and an on-site injunction resulting in the immediate shut down of operations in January of 2014, The FDA Group lead a team of consultants to work closely with internal personnel at a large healthcare Company to plan and execute a comprehensive remediation project beginning in June of 2014.

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  • What prompted FDA to immediately shut down operations at the Company following a routine facility inspection
  • How The FDA Group worked closely with the Company's quality and compliance personnel to conduct a quality system audit, record review, and remediation project while training and mentoring staff to solidify duties and responsibilities throughout the site
  • How The FDA Group identified significant gaps in the Company's go-to-market strategy, trained staff in accordance with FDA expectations, and continues to manage improvement projects
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