# FDA 483 - The A.R.T. Institute of Washington, Inc. - June 08, 2022

Source: https://www.globalkeysolutions.net/records/483/the-art-institute-of-washington-inc/750f9eb0-54f4-4565-882e-fb5540a8ce36

> FDA 483 for The A.R.T. Institute of Washington, Inc. on June 08, 2022. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: The A.R.T. Institute of Washington, Inc.
- Inspection Date: 2022-06-08
- Product Type: biologics
- Office Name: Office of Regulatory Affairs
- Summary: An FDA inspection of The A.R.T. Institute of Washington, Inc. in Bethesda, MD, a reproductive human tissue establishment, revealed significant deficiencies in donor eligibility determination. The firm failed to adequately test and screen donors for communicable disease agents, use FDA-licensed tests, collect samples at appropriate times, and maintain complete medical records. Additionally, the facility did not quarantine HCT/Ps properly or establish and maintain adequate written procedures for donor testing and screening.

## Related Officers

- [La-tasha M. Gunter](https://www.globalkeysolutions.net/people/la-tasha-m-gunter/db9cd9cf-db0a-4c31-9f7c-24760750f34d)

Company: https://www.globalkeysolutions.net/companies/the-art-institute-of-washington-inc/e6e87941-e5a2-4b8d-8e81-033ed17785a4

Office: https://www.globalkeysolutions.net/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64