483
Delaware Institute for Reproductive Medicine, P.AFDA 483 - Delaware Institute for Reproductive Medicine, P.A - June 20, 2019
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Record Details
The FDA inspected Delaware Institute for Reproductive Medicine, P.A. in Newark, DE, from June 18-20, 2019, and issued a Form 483. The inspection revealed a significant deficiency in donor screening practices, specifically regarding the assessment of risk factors for Zika Virus in oocyte donors. This indicates a serious lapse in ensuring donor eligibility and preventing the transmission of communicable diseases.
- Inspection Date
- June 20, 2019
- Product Type
- Biologics
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ID · 904527b4-d732-4d05-b797-0c7f9d851ccc