News and Press Releases
February 4, 2010, Germantown, MD - Amarex Passes FDA Audit with High Compliments from FDA AuditorAmarex Clinical Research was informed by the FDA that Amarex had been randomly selected for a GCP audit of her CRO services business, giving Amarex less than a week to prepare. "The result of the audit was a resounding ‘A+ grade’ for Amarex", according to Dr. Mukesh Kumar, Amarex’s Sr. Director of Regulatory Affairs. "The FDA auditor was very complimentary of Amarex’s SOPs, documentation system and training program, calling them 'some of the best in the industry' based on her many years of auditing experience." Documentation from several randomly selected clinical trials conducted over the last 3 years was also audited and given a clean bill of health...No 483s...No minor observations and a recommendation of No Action Indicated (NAI).
Dr. Kumar added, "I was confident Amarex was in very good shape regarding GCP regulatory compliance, but it was especially gratifying to have no findings and to have the FDA auditor be so complimentary of Amarex."
The FDA’s formal report will be processed and posted to the FDA website sometime this month.
Amarex is a global CRO headquartered in Montgomery County Maryland that provides consulting, regulatory and clinical trial services for medical product development and market approval.
Contact: info@amarexcro.com
Letter from the FDA