# FDA 483 - Versiti Indiana Inc - May 07, 2019

Source: https://www.globalkeysolutions.net/records/483/versiti-indiana-inc/4b39e8da-04cc-4902-9542-1a53ca0a7a74

> FDA 483 for Versiti Indiana Inc on May 07, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Versiti Indiana Inc
- Inspection Date: 2019-05-07
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: An FDA inspection of Versiti Indiana Inc, a blood bank in Indianapolis, revealed significant deficiencies in equipment maintenance, labeling, record-keeping, and adherence to standard operating procedures for HCT/Ps and blood products. Issues included unmaintained cryogenic freezers, improperly labeled tissues, unrecorded storage temperatures, and missing or incomplete documentation for processing and distribution steps. These observations indicate a lack of control over critical processes impacting product quality and traceability.

## Related Officers

- [Lewis K. Antwi](https://www.globalkeysolutions.net/people/lewis-k-antwi/8ab4f1c7-8b5b-4556-98a4-6edc3bc49470)

Company: https://www.globalkeysolutions.net/companies/versiti-indiana-inc/15995c39-b008-465c-b771-a56c8206cf2a

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0