# FDA 483 - Stericycle Inc - February 18, 2025

Source: https://www.globalkeysolutions.net/records/483/stericycle-inc/cc392245-26c3-4358-ac71-c257e4bcc6a2

> FDA 483 for Stericycle Inc on February 18, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Stericycle Inc
- Inspection Date: 2025-02-18
- Product Type: device
- Office Name: Chicago District Office
- Summary: Stericycle Inc. in Bannockburn, IL, a medical device manufacturer of sharps containers, was cited with six observations during an FDA inspection from February 11-18, 2025. The inspection revealed significant deficiencies across multiple quality system areas, including inadequate procedures for corrective and preventive actions, purchasing controls, complaint handling, design control, servicing activities, and control of nonconforming product. Several observations were repeats from previous inspections, indicating persistent issues with the firm's quality management system.

## Related Documents

- [483 - 2020-02-27](https://www.globalkeysolutions.net/records/483/stericycle-inc/6b621dcb-9011-467e-a41c-eafac827fecd)

## Related Officers

- [Chad E. Schmear](https://www.globalkeysolutions.net/people/chad-e-schmear/275a4c57-d288-46f9-8257-64fcd96159ce)

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