# FDA 483 - Dr. Louis R. Manara - January 28, 2020

Source: https://www.keypedia.com/records/483/dr-louis-r-manara/eae1e173-e57f-4b3e-ac12-4f8b4ea571cd

> FDA 483 for Dr. Louis R. Manara on January 28, 2020. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dr. Louis R. Manara
- Inspection Date: 2020-01-28
- Product Type: other
- Office Name: Philadelphia District Office
- Summary: An FDA inspection of Dr. Louis R. Manara, a human tissue reproductive establishment in Voorhees, NJ, revealed critical failures in donor screening. The firm did not adequately test oocyte donors for communicable disease agents and failed to deem ineligible a donor who tested positive for Chlamydia trachomatis, leading to the use and banking of embryos from this donor.

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## Related Officers

- [Nikisha Rolden](https://www.keypedia.com/people/nikisha-rolden/ccd5f87b-fb28-493d-b0a5-2ebde50461be)

Company: https://www.keypedia.com/companies/dr-louis-r-manara/4b0cc23b-4140-4404-b357-4c5e1351800b

Office: https://www.keypedia.com/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8