# FDA 483 - Sterling Regional Medical Center - September 19, 2024

Source: https://www.keypedia.com/records/483/sterling-regional-medical-center/65fdcd79-3412-4731-8779-540dfb4d2326

> FDA 483 for Sterling Regional Medical Center on September 19, 2024. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sterling Regional Medical Center
- Inspection Date: 2024-09-19
- Product Type: biologics
- Office Name: Denver District Office
- Summary: An FDA inspection of Sterling Regional MedCenter's Blood Bank in Sterling, CO, revealed significant deficiencies in record-keeping practices. The facility failed to ensure that quality control logs and maintenance records were properly reviewed by section heads and laboratory managers as required by their standard operating procedures. This indicates a lapse in oversight and documentation integrity for critical blood bank operations.

## Related Officers

- [Ismael Olvera](https://www.keypedia.com/people/ismael-olvera/0fa45168-6e5f-4eb5-9a3d-4ff8992f84d2)
- [FDA_PERSONNEL](https://www.keypedia.com/people/deepa-e-vadakkan/89c0e1c7-4f9e-4668-81a8-e5a9ab6a0e34)

Company: https://www.keypedia.com/companies/sterling-regional-medical-center/558157da-26b6-48fc-9d81-9b348dc65404

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face