# FDA 483 - Advanced Engineering, Inc. - September 18, 2019

Source: https://www.keypedia.com/records/483/advanced-engineering-inc/1a6bc25f-dc77-45bc-8647-0bfe5de18437

> FDA 483 for Advanced Engineering, Inc. on September 18, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Advanced Engineering, Inc.
- Inspection Date: 2019-09-18
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: An FDA inspection of Advanced Engineering, Inc. in Huntington, IN, a medical device manufacturer, revealed significant deficiencies in their quality system. The firm failed to adequately validate processes, lacking predetermined acceptance criteria and using inconsistent parameters. Additionally, their risk analysis was found to be inadequate, specifically regarding the failure to update a Process FMEA after a product complaint involving misassembled device components.

## Related Officers

- [Debara R. Reese](https://www.keypedia.com/people/debara-r-reese/277a8fbb-ba4d-4402-be08-16d7977685db)

Company: https://www.keypedia.com/companies/advanced-engineering-inc/19f8c15d-950a-4fed-b4e9-39f0ecbd605a

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0