SYNTHES SPINAL INSTRUMENT PROCESS VALIDATION GMP DEFICIENCIES

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."