# FDA 483 - ImpactOrtho Inc - February 06, 2025

Source: https://www.keypedia.com/records/483/impactortho-inc/7c883fde-5019-4057-901a-1020461f4499

> FDA 483 for ImpactOrtho Inc on February 06, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ImpactOrtho Inc
- Inspection Date: 2025-02-06
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: ImpactOrtho Inc, an HCT/P distributor in Tempe, AZ, was cited for significant deficiencies during an FDA inspection. Observations included a failure to record and maintain storage temperatures for HCT/P products, an inadequate quality program lacking procedures for temperature alarm investigations, and non-adherence to equipment maintenance procedures, specifically regarding freezer qualification and alarm checks. These issues indicate a lack of control over critical storage conditions for distributed HCT/Ps.

## Related Documents

- [483 - 2025-02-06](https://www.keypedia.com/records/483/impactortho-inc/458bd45c-5129-4298-9e5e-a62e62c8bef9)

## Related Officers

- [Emily S. McGann](https://www.keypedia.com/people/emily-s-mcgann/43891ff3-bd70-4337-b61c-e16cc7ad0468)

Company: https://www.keypedia.com/companies/impactortho-inc/78a4b4ab-3b24-4555-99de-66034a688bf7

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6