SYNTHES SPINAL INSTRUMENT PROCESS VALIDATION GMP DEFICIENCIES
This article was originally published in The Gray Sheet
Executive Summary
SYNTHES SPINAL INSTRUMENT PROCESS VALIDATION GMP DEFICIENCIES result in receipt of a warning letter from FDA. Following inspections of the company's Exton and Paoli, Pennsylvania facilities conducted Aug. 9-26, the agency concluded in the Sept. 23 letter that the company's process validation procedures are not "adequate to assure product integrity."
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