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EIR availability to manufacturers could prevent inappropriate warning letters, MDMA counsel Pilot says.

This article was originally published in The Gray Sheet

Executive Summary

GMP INSPECTION REPORT AVAILABILITY TO FIRMS PRIOR TO FDA ENFORCEMENT DECISION could help prevent inappropriate warning letters, Larry Pilot, McKenna & Cuneo attorney and counsel to the Medical Device Manufacturers Association, says in a May 24 letter to FDA. "Many manufacturers have experienced the trauma of a warning letter because of incorrect and uncontradicted statements made in" an establishment inspection report, Pilot says in the letter to Joseph Levitt, deputy director for regulations and policy at FDA's Center for Devices and Radiological Health. "These unfortunate experiences...could have been avoided if the manufacturer had access to and the opportunity to comment on the EIR prior to any enforcement decision by FDA."

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