# FDA 483 - The Morel Company, LLC - November 01, 2018

Source: https://www.keypedia.com/records/483/the-morel-company-llc/0b2ffcde-c75d-4048-b981-d451a503d033

> FDA 483 for The Morel Company, LLC on November 01, 2018. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: The Morel Company, LLC
- Inspection Date: 2018-11-01
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: An FDA inspection of The Morel Company, LLC, a medical device manufacturer in Batesville, IN, identified a repeat observation regarding inadequate procedures for the rework of nonconforming products. Specifically, the firm failed to document adverse impact assessments in device history records after rework and re-evaluation activities. This indicates a persistent issue with quality system controls.

## Related Documents

- [483 - 2018-11-01](https://www.keypedia.com/records/483/the-morel-company-llc/8929eb84-d578-47e8-bac7-7aaf4d5f197c)

## Related Officers

- [Consumer Safety Officer, Medical Device Specialist](https://www.keypedia.com/people/teresa-kastner/32a8d75e-770d-48cc-80e0-2eb5ad57e560)

Company: https://www.keypedia.com/companies/the-morel-company-llc/52396817-9113-4c3c-b344-e318e5ad2859

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