# FDA 483 - Active Medical - December 12, 2019

Source: https://www.globalkeysolutions.net/records/483/active-medical/92f24b8b-9c7a-4bdd-837c-e2c181a37e91

> FDA 483 for Active Medical on December 12, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Active Medical
- Inspection Date: 2019-12-12
- Product Type: biologics
- Office Name: Denver District Office
- Summary: Restore Medical in Sandy, UT, an HCT/P storage and distributor, was cited for significant deficiencies during an FDA inspection. Observations included a failure to record and review HCT/P storage temperatures, lack of established and approved procedures for handling HCT/Ps, and an absence of a formal personnel training program. These issues indicate a lack of adequate controls and documentation for critical operations.

## Related Officers

- [Emily B. Camire](https://www.globalkeysolutions.net/people/emily-b-camire/dff5f4c6-bcbe-4ef1-ac0b-1b2701b311ef)

Company: https://www.globalkeysolutions.net/companies/active-medical/6922ab0e-6033-471a-89df-aba591eaf2a5

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