# FDA 483 - New York Blood Center Enterprises - January 16, 2018

Source: https://www.globalkeysolutions.net/records/483/new-york-blood-center-enterprises/9d74f045-3a61-432e-97f9-ee9f76608431

> FDA 483 for New York Blood Center Enterprises on January 16, 2018. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: New York Blood Center Enterprises
- Inspection Date: 2018-01-16
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: The FDA issued a Form 483 to New York Blood Center, Inc. in Melville, NY, following an inspection of their Donor Center. The inspection revealed deficiencies related to equipment performance, specifically the use of a non-calibrated scale for blood collection, and a failure to maintain adequate quality control and general records, including a lack of documented staff training for donor weight scales. These issues indicate a need for improved adherence to established procedures and record-keeping practices.

## Related Documents

- [483 - 2020-11-09](https://www.globalkeysolutions.net/records/483/new-york-blood-center-enterprises/8385b3f9-128a-478b-b6b1-af023182fa15)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/irina-gaberman/c863b2de-4c64-40d2-a390-289d293e5a8f)

Company: https://www.globalkeysolutions.net/companies/new-york-blood-center-enterprises/633527fd-9f5f-415c-9008-e8ec548c7b13

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