# FDA 483 - ImpactOrtho Inc Hawaii - February 28, 2019

Source: https://www.keypedia.com/records/483/impactortho-inc-hawaii/1e02273d-06e9-42a0-825d-966b92dd4713

> FDA 483 for ImpactOrtho Inc Hawaii on February 28, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ImpactOrtho Inc Hawaii
- Inspection Date: 2019-02-28
- Product Type: biologics
- Office Name: Minneapolis District Office
- Summary: Spon-stek Medical Inc, Hawaii, was inspected for HCT/P storage and distribution and received a Form 483 with three observations. The firm failed to establish and maintain a quality program and appropriate procedures for HCT/P manufacturing steps. Significant issues were noted with inventory control, including missing HCT/Ps and a lack of temperature monitoring records for storage areas.

## Related Officers

- [Susan M North](https://www.keypedia.com/people/susan-m-north/28518e5b-45b9-4405-a033-baa1cdb1bdc6)

Company: https://www.keypedia.com/companies/impactortho-inc-hawaii/5ad1174a-8c89-4370-9957-70bdb79b31a6

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d