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Remediation Project: Massachusetts

During the calendar year of 2015 and continuing to the present day, The FDA Group assisted in the planning and execution of a comprehensive remediation project in response to Warning Letters issued to a large healthcare Company citing a range of deficiencies.

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• Which kinds of compliance problems were cited in the Warning Letters
• How The FDA Group worked closely with the Company's quality and compliance personnel to assess the current quality plan, conduct thorough record reviews, and write new protocols
• How The FDA Group identified eight significant deficiencies in all subparts of CAPA and improved internal processes to successfully resolve those issues