# FDA 483 - Slice Manufacturing LLC - July 22, 2019

Source: https://www.globalkeysolutions.net/records/483/slice-manufacturing-llc/8feae19e-9975-4763-bac6-53ccc318ce6a

> FDA 483 for Slice Manufacturing LLC on July 22, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Slice Manufacturing LLC
- Inspection Date: 2019-07-22
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: Slice Manufacturing LLC in Akron, OH, a medical device manufacturer, was inspected by the FDA from July 11-22, 2019. The inspection revealed significant deficiencies in process validation, acceptance procedures for in-process product, control of non-conforming product, device history records, and the development of production processes, particularly concerning acetabular cups. These issues indicate a lack of adequate quality system controls for manufacturing medical devices.

## Related Officers

- [Investigator ](https://www.globalkeysolutions.net/people/benjamin-j-dastoli/688c2ad7-f7ac-47eb-8ca2-4efcd221f636)

Company: https://www.globalkeysolutions.net/companies/slice-manufacturing-llc/f7c184d0-a915-4651-b872-b0243b0b3aa1

Office: https://www.globalkeysolutions.net/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22