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INTERMEDICS THIRD-PARTY CERTIFICATION OF GMP COMPLIANCE

This article was originally published in The Gray Sheet

Executive Summary

INTERMEDICS THIRD-PARTY CERTIFICATION OF GMP COMPLIANCE is under way in response to a July 27 warning letter from FDA requesting the certification. The warning letter, which followed a March 7 to April 26 inspection of the company's pacemaker manufacturing facility in Angleton, Texas, cites the company's repeated deviations from good manufacturing practice regulations.

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