# FDA 483 - Memorial Sloan Kettering Cancer Center - September 20, 2022

Source: https://www.keypedia.com/records/483/memorial-sloan-kettering-cancer-center/9a253fe4-a3ac-4148-94a2-2784c6ae8696

> FDA 483 for Memorial Sloan Kettering Cancer Center on September 20, 2022. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Memorial Sloan Kettering Cancer Center
- Inspection Date: 2022-09-20
- Product Type: other
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Memorial Sloan Kettering Cancer Center's Non-Clinical Laboratory in New York, NY, revealed several deficiencies. Observations included failures to conduct nonclinical laboratory studies in accordance with protocols, improper identification of specimens, and inadequate maintenance of the master schedule sheet by the quality assurance unit. These issues indicate a lack of adherence to established procedures and documentation requirements for nonclinical studies.

## Related Documents

- [483 - 2018-11-09](https://www.keypedia.com/records/483/memorial-sloan-kettering-cancer-center/c1454d69-c1e7-4125-821f-cfdcd5073540)

## Related Officers

- [Byungja E. Marciante](https://www.keypedia.com/people/byungja-e-marciante/5d1f2927-9017-4ab6-8ad2-521e340ef14f)
- [Kerun Hardeo](https://www.keypedia.com/people/kerun-hardeo/d6c75a34-ab9b-4541-883d-102c6ec8c131)

Company: https://www.keypedia.com/companies/memorial-sloan-kettering-cancer-center/95fe4e95-55b4-4888-9e24-68c9d704b378

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961