# FDA 483 - Advanced Medical Innovations - August 20, 2021

Source: https://www.globalkeysolutions.net/records/483/advanced-medical-innovations/10c5c004-5f93-4257-a873-e17247eeadf4

> FDA 483 for Advanced Medical Innovations on August 20, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Advanced Medical Innovations
- Inspection Date: 2021-08-20
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Advanced Medical Innovations, a Class I and II medical device manufacturer in Northridge, CA, revealed a significant quality system deficiency. The firm failed to adequately validate processes for sterile Ultimate Sharp Safety Stations, specifically by not conducting required dose audits and bioburden testing for several years. This indicates a serious lapse in ensuring product sterility and safety.

## Related Officers

- [Kelvin Cheung](https://www.globalkeysolutions.net/people/kelvin-cheung/ded61aee-4b4b-4049-a67c-19d971475be7)

Company: https://www.globalkeysolutions.net/companies/advanced-medical-innovations/71bef981-afc7-4095-893a-78f6f71f70cb

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