483
Shore Institute For Reproductive Medicine, P.C.FDA 483 - Shore Institute For Reproductive Medicine, P.C. - March 29, 2011
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Record Details
An FDA inspection of Shore Institute For Reproductive Medicine, P.C. in Lakewood, NJ, from March 23-29, 2011, revealed a significant deficiency in donor screening practices. The firm failed to adequately screen donors for risk factors of communicable diseases, specifically regarding the risk of contracting CJD or vCJD from blood transfusions in France.
- Inspection Date
- March 29, 2011
- Product Type
- Biologics
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ID · 3e465f41-d13b-474c-9d47-6a8a9e2b2080