# FDA 483 - Donor Center Of Nybc - August 03, 2022

Source: https://www.globalkeysolutions.net/records/483/donor-center-of-nybc/94806c26-e9df-4986-94ea-0bee033a07a6

> FDA 483 for Donor Center Of Nybc on August 03, 2022. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Donor Center Of Nybc
- Inspection Date: 2022-08-03
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Donor Center of Nybc in Rockville Centre, NY, from July 19 to August 3, 2022, revealed that the firm failed to consistently follow its written standard operating procedures for the collection of blood and blood components. Specifically, procedures for platelet collection timing and visual inspection during medical interviews were not adhered to. This indicates a lapse in procedural compliance that could impact product quality and donor safety.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/donor-center-of-nybc/cd3eaba2-84f4-4697-b01b-413cda655faf

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