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Warning Letter Roundup: FDA Enforcement And Compliance In Brief

Executive Summary

Data integrity issues bedevil Chinese API firm Suzhou Pharmaceutical Technology and Japanese manufacturer Sato Yakuhin; inadequate sterility controls net warning letters for Brazilian firm Antibioticos Do Brasil, and US firms Horizon, Pharm D, and Aplicare; and lack of a functioning quality unit observed at Canadian firm Intega in FDA GMP warning letters issued in December and January.

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