# FDA 483 - Vitalant - June 19, 2019

Source: https://www.globalkeysolutions.net/records/483/vitalant/a1911bf5-5fda-4eb2-bf44-f4d815e5319c

> FDA 483 for Vitalant on June 19, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Vitalant
- Inspection Date: 2019-06-19
- Product Type: biologics
- Office Name: New Orleans District Office
- Summary: An FDA inspection of Vitalant, a blood bank and donor collection center in Lafayette, LA, identified a failure to maintain quality control records. Specifically, the firm lacked documentation of antigen typing quality control results for specific antigens on multiple dates. This indicates a deficiency in record-keeping practices for critical quality control procedures.

## Related Officers

- [Richard J. Bashay](https://www.globalkeysolutions.net/people/richard-j-bashay/ce50702d-1f5b-42c5-b50a-88bb43cba196)

Company: https://www.globalkeysolutions.net/companies/vitalant/7fac93ca-3e09-41a7-9105-8c108be93855

Office: https://www.globalkeysolutions.net/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea