483
Southern California Center for Reproductive MedicineFDA 483 - Southern California Center for Reproductive Medicine - January 20, 2023
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Record Details
The FDA issued a Form 483 to Southern California Center for Reproductive Medicine, a reproductive fertility center in Newport Beach, CA, following an inspection. The inspection revealed significant deficiencies in donor screening for communicable diseases, including West Nile Virus, HIV, Hepatitis B, and CJD/TSE. Additionally, the firm lacked adequate procedures for donor eligibility and failed to maintain donor anonymity in accompanying records.
- Inspection Date
- January 20, 2023
- Product Type
- Biologics
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ID · 6829d250-76f8-4ee1-b7d8-881b86771c29