# FDA 483 - NIH Donor Center at Fishers Lane - July 11, 2019

Source: https://www.globalkeysolutions.net/records/483/nih-donor-center-at-fishers-lane/d3d711d4-fd96-4f9e-9477-4e13263dd235

> FDA 483 for NIH Donor Center at Fishers Lane on July 11, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: NIH Donor Center at Fishers Lane
- Inspection Date: 2019-07-11
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: The FDA inspected the NIH Donor Center at Fishers Lane in Rockville, MD, from July 8-11, 2019, revealing significant issues related to donor safety and procedural compliance. Observations included the failure of physicians to explain plateletpheresis risks to donors, inadequate collection of donor contact information, and a general failure to consistently follow written standard operating procedures for blood and blood component collection. These findings indicate deficiencies in donor consent processes and adherence to established protocols.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/shavon-l-square/6a15df34-1af6-44f7-8874-c8606691f7e0)

Company: https://www.globalkeysolutions.net/companies/nih-donor-center-at-fishers-lane/d7c2e9f2-6a4f-4d3d-9bd5-b7ae6341d2a8

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-ii/a9ab7e08-db36-4350-a7d7-6a61dc61250e