# FDA 483 - Veridian Healthcare - November 28, 2018

Source: https://www.globalkeysolutions.net/records/483/veridian-healthcare/507a6b0f-b3cc-4a1a-b199-2e21bf0c375d

> FDA 483 for Veridian Healthcare on November 28, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Veridian Healthcare
- Inspection Date: 2018-11-28
- Product Type: drugs
- Office Name: Chicago District Office
- Summary: Veridian Healthcare, LLC, an own label distributor in Gurnee, IL, was cited for multiple deficiencies related to quality control, complaint handling, adverse event reporting, and recall procedures. The inspection revealed a lack of authority for the quality unit, failure to follow written procedures, inadequate complaint investigations, and unreported adverse drug events. Additionally, the firm lacked a written recall procedure for drug products.

## Related Officers

- [Michele L. Glendenning](https://www.globalkeysolutions.net/people/michele-l-glendenning/a3c23a43-634c-4140-807b-c17fbc03bb00)

Company: https://www.globalkeysolutions.net/companies/veridian-healthcare/df10533a-aaf4-4272-8010-4404846989a4

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