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3M's Northridge, Calif. plant subject of Dec. 7 FDA warning letter on lab control practices.

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Executive Summary

3M NORTHRIDGE, CALIF. PLANT FAILED "TO CONTROL LAB CONTROL MECHANISMS to assure that components, in-process materials and drug products conform to appropriate standards of identity, strength, quality and purity," FDA said in a Dec. 7 warning letter. Resulting from inspections of the manufacturing facility conducted Nov. 14-27, the letter notes several departures from current Good Manufacturing Practice regulations.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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