# FDA 483 - Dr. Louis R. Manara - October 21, 2021

Source: https://www.keypedia.com/records/483/dr-louis-r-manara/3b7ec250-afbe-4f93-b4ab-cd35e325cafb

> FDA 483 for Dr. Louis R. Manara on October 21, 2021. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dr. Louis R. Manara
- Inspection Date: 2021-10-21
- Product Type: biologics
- Office Name: Philadelphia District Office
- Summary: An FDA inspection of Dr. Louis R. Manara, a human tissue reproductive establishment in Voorhees, NJ, revealed a significant deficiency in donor screening. The firm failed to test anonymous oocyte donors for relevant communicable disease agents, specifically West Nile Virus, before deeming them eligible to donate. This indicates a serious lapse in ensuring donor safety and compliance with regulations for human tissue products.

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## Related Officers

- [Kish Bolden](https://www.keypedia.com/people/kish-bolden/e24957d4-927f-40c7-a7ca-860fedce2e3f)

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