# FDA 483 - Liquid Crystal Resources Hallcrest LLC - October 01, 2019

Source: https://www.globalkeysolutions.net/records/483/liquid-crystal-resources-hallcrest-llc/7755f137-cf35-490a-b2de-bc89723b8dc5

> FDA 483 for Liquid Crystal Resources Hallcrest LLC on October 01, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Liquid Crystal Resources Hallcrest LLC
- Inspection Date: 2019-10-01
- Product Type: device
- Office Name: Chicago District Office
- Summary: Liquid Crystal Resources Hallcrest LLC, a manufacturer in Glenview, IL, was cited for significant quality system deficiencies during an FDA inspection. Observations included inadequate validation of software and manufacturing processes, deficiencies in corrective and preventive action procedures, and incomplete device history records. The firm also failed to adequately manage complaints and maintain device master records, indicating systemic issues in its quality management system.

## Related Officers

- [Recall Coordinator](https://www.globalkeysolutions.net/people/emma-schaefer/10299982-dce6-4fea-a3e9-8167030b0331)

Company: https://www.globalkeysolutions.net/companies/liquid-crystal-resources-hallcrest-llc/69c2c4c9-9fdc-49dc-bf70-be1b18ca8dfc

Office: https://www.globalkeysolutions.net/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669