# FDA 483 - Maimonides Medical Center - August 15, 2024

Source: https://www.globalkeysolutions.net/records/483/maimonides-medical-center/f03d0878-cf99-4205-b383-9e4ee74b13c0

> FDA 483 for Maimonides Medical Center on August 15, 2024. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Maimonides Medical Center
- Inspection Date: 2024-08-15
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Maimonides Medical Center's Blood Bank & Donor Room identified significant deficiencies in record-keeping practices. The firm failed to concurrently maintain detailed records for blood and blood component collection and processing, impacting traceability and donor eligibility determinations. Issues included inadequate donor verification, illegible documentation, unapproved validation records, and improper use of correction tape on quality control records.

## Related Officers

- [Amy Kim](https://www.globalkeysolutions.net/people/amy-kim/eee8b97a-b9d0-4709-96dc-70dbadd3a6a4)
- [Amy W. Yan-Mai](https://www.globalkeysolutions.net/people/amy-w-yan-mai/00551315-3a03-4327-ab3a-71de5c1577d4)

Company: https://www.globalkeysolutions.net/companies/maimonides-medical-center/589df1a2-cd5b-4b64-a5bc-1305a06204ae

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