FDA 483 - Lucile Salter Packard Children's Hospital Stanford Medicine Fertility and Reproductive Health - April 27, 2023
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An FDA inspection of Lucile Salter Packard Children's Hospital Stanford Medicine Fertility and Reproductive Health in Sunnyvale, CA, identified a critical issue with communicable disease testing. The firm failed to adhere to manufacturer's instructions for collecting urine specimens from reproductive cell and tissue donors. This non-compliance involved incorrect urine volumes and collection methods, potentially compromising the sensitivity of tests for Chlamydia trachomatis and Neisseria gonorrhea.
- Company
- Lucile Salter Packard Children's Hospital Stanford Medicine Fertility and Reproductive Health
- Inspection Date
- April 27, 2023
- Product Type
- Biologics
ID · fa0ef781-44ec-4443-b56f-0faace02af14