# FDA 483 - Stericycle Inc - December 21, 2023

Source: https://www.globalkeysolutions.net/records/483/stericycle-inc/9da92d69-9293-4a4f-9daa-d7bd5afd2903

> FDA 483 for Stericycle Inc on December 21, 2023. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Stericycle Inc
- Inspection Date: 2023-12-21
- Product Type: other
- Office Name: Chicago District Office
- Summary: An FDA inspection of Stericycle Inc. in Aurora, IL, a manufacturer of Class II containers, revealed significant deficiencies in its quality management system. The firm failed to conduct required management reviews and internal quality audits, both of which were repeat observations from a previous inspection. Additionally, the company did not adequately establish procedures for corrective and preventive actions, failing to document non-conformances and verify the effectiveness of implemented actions.

## Related Officers

- [Brittani N. Franklin](https://www.globalkeysolutions.net/people/brittani-n-franklin/1d5e9344-1145-42ff-a175-5541b565b15e)

Company: https://www.globalkeysolutions.net/companies/stericycle-inc/a1207132-e501-4da5-961c-478ba7eafb54

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