# FDA 483 - Parkview Health Laboratories - January 30, 2025

Source: https://www.globalkeysolutions.net/records/483/parkview-health-laboratories/533726a4-a14c-4a3b-9f2a-1a0d9d31c770

> FDA 483 for Parkview Health Laboratories on January 30, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Parkview Health Laboratories
- Inspection Date: 2025-01-30
- Product Type: biologics
- Office Name: Detroit District Office
- Summary: An FDA inspection of Parkview Health Laboratories' Hospital Blood Bank in Fort Wayne, IN, revealed a significant deficiency in record-keeping for emergency transfusions. The facility failed to maintain records, including physician signatures, for numerous emergency and massive transfusion events, instead documenting verbal consents or nurse signatures. This indicates a serious lapse in ensuring proper authorization and documentation for critical blood product releases.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/parkview-health-laboratories/bf48485f-3a9d-4370-9365-611c94efcac0

Office: https://www.globalkeysolutions.net/offices/detroit-district-office/b09a1815-a000-40c0-bb44-5432ce87ed03