# FDA 483 - RR Donnelley - Supply Chain Solutions - September 29, 2023

Source: https://www.keypedia.com/records/483/rr-donnelley-supply-chain-solutions/164cd320-9f73-4905-b48d-bbbeec03989a

> FDA 483 for RR Donnelley - Supply Chain Solutions on September 29, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: RR Donnelley - Supply Chain Solutions
- Inspection Date: 2023-09-29
- Product Type: drugs
- Office Name: Chicago District Office
- Summary: An FDA inspection of RR Donnelley - Supply Chain Solutions in Plover, WI, revealed significant deficiencies in their quality system. The firm failed to adequately establish and document corrective and preventive action procedures, including issues with supplier validation and record completeness. Additionally, procedures for equipment maintenance were found to be inadequate, and management did not ensure the quality policy was understood by all employees.

## Related Officers

- [Medical Device Specialist](https://www.keypedia.com/people/jesse-a-vazquez/cac5b170-d0ea-4355-af5d-3d81546ff0fe)

Company: https://www.keypedia.com/companies/rr-donnelley-supply-chain-solutions/91274598-4770-41d8-b8d0-d029abfb4c25

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