# FDA 483 - Advanced Concept Innovations LLC - August 17, 2017

Source: https://www.globalkeysolutions.net/records/483/advanced-concept-innovations-llc/b79dc4cb-4d73-43cd-96d9-6fdc40a36290

> FDA 483 for Advanced Concept Innovations LLC on August 17, 2017. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Advanced Concept Innovations LLC
- Inspection Date: 2017-08-17
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Advanced Concept Innovations, Llc, a medical device contract manufacturer in Lakeland, FL, revealed significant deficiencies in their quality system. Observations included inadequate process validation for clean rooms and sealing processes, insufficient procedures for purchasing and supplier management, and a lack of documented software validation activities for manufacturing and quality systems.

## Related Officers

- [Principal ](https://www.globalkeysolutions.net/people/richard-k-vogel/3ddd8bff-24fd-40ee-b0a7-fb5333a520f5)

Company: https://www.globalkeysolutions.net/companies/advanced-concept-innovations-llc/72b18f93-e63a-40d3-9497-318783d83837

Office: https://www.globalkeysolutions.net/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6