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483
•Liquid Crystal Resources Hallcrest LLC•October 1, 2019

Liquid Crystal Resources Hallcrest LLC – FDA 483, Oct 1, 2019

Record Details

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.

Company
Liquid Crystal Resources Hallcrest LLC
Inspection date
October 1, 2019
Product type
device
Office
Chicago District Office
Person
  • Emma Schaefer (Recall Coordinator)
View Company Profile

ID · 7755f137-cf35-490a-b2de-bc89723b8dc5

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