# FDA 483 - Versiti Illinois Inc - August 12, 2019

Source: https://www.keypedia.com/records/483/versiti-illinois-inc/94e41d92-e58b-4254-8bef-deb9b37584dd

> FDA 483 for Versiti Illinois Inc on August 12, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Versiti Illinois Inc
- Inspection Date: 2019-08-12
- Product Type: biologics
- Office Name: Chicago District Office
- Summary: An FDA inspection of Versiti Illinois Inc, a blood bank in Tinley Park, IL, identified a significant lapse in quality control. The firm failed to conduct thorough investigations into unexplained discrepancies, specifically regarding 27 units of blood products that were reported lost over a two-year period. This indicates a serious concern with the firm's record-keeping and investigation procedures for critical biological products.

## Related Officers

- [Susan M North](https://www.keypedia.com/people/susan-m-north/28518e5b-45b9-4405-a033-baa1cdb1bdc6)
- [Lewis K. Antwi](https://www.keypedia.com/people/lewis-k-antwi/8ab4f1c7-8b5b-4556-98a4-6edc3bc49470)

Company: https://www.keypedia.com/companies/versiti-illinois-inc/5cec847c-d940-4152-bc13-b3aa61e3ebe4

Office: https://www.keypedia.com/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669