# FDA 483 - Stericycle Inc - February 27, 2020

Source: https://www.globalkeysolutions.net/records/483/stericycle-inc/6b621dcb-9011-467e-a41c-eafac827fecd

> FDA 483 for Stericycle Inc on February 27, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Stericycle Inc
- Inspection Date: 2020-02-27
- Product Type: device
- Office Name: Chicago District Office
- Summary: Stericycle Inc. in Northbrook, IL, a specifications developer/refurbisher, was cited with six observations during an FDA inspection from February 24-27, 2020. The inspection revealed significant deficiencies in their quality system, particularly concerning corrective and preventive actions, record-keeping, organizational structure, quality policy establishment, quality audits, and software validation. Several issues, including CAPA procedures, were noted as repeat observations from a previous 2012 FDA inspection, indicating persistent non-compliance.

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- [483 - 2025-02-18](https://www.globalkeysolutions.net/records/483/stericycle-inc/cc392245-26c3-4358-ac71-c257e4bcc6a2)

## Related Officers

- [Javelle P. Spann](https://www.globalkeysolutions.net/people/javelle-p-spann/31a8f7a8-e442-4f5a-b33f-55bfe911e61b)
- [Medical Device Specialist](https://www.globalkeysolutions.net/people/jesse-a-vazquez/cac5b170-d0ea-4355-af5d-3d81546ff0fe)

Company: https://www.globalkeysolutions.net/companies/stericycle-inc/85b834aa-1ec7-4be5-9adc-6b3750c03c17

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