# FDA 483 - Decatur Memorial Hospital - PET Production - January 15, 2026

Source: https://www.keypedia.com/records/483/decatur-memorial-hospital-pet-production/873a8304-1826-4757-9bb8-cadcd6f330ca

> FDA 483 for Decatur Memorial Hospital - PET Production on January 15, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Decatur Memorial Hospital - PET Production
- Inspection Date: 2026-01-15
- Product Type: drugs
- Office Name: Chicago District Office
- Summary: Sofie Co. dba SOFIE, a PET Drug Manufacturer in Decatur, IL, was cited for significant deficiencies in its quality system. The inspection revealed failures to adequately investigate out-of-specification results and deviations, leading to ineffective corrective and preventive actions. Additionally, the firm lacked sufficient controls over production and laboratory data acquisition systems, compromising data integrity and record retention.

## Related Officers

- [Shannon L. Maisano](https://www.keypedia.com/people/shannon-l-maisano/2cce259d-0fbe-44ef-b43e-7292da739470)
- [Monica E. Murie](https://www.keypedia.com/people/monica-e-murie/2db840df-d69f-4def-9830-fd461bea5507)

Company: https://www.keypedia.com/companies/decatur-memorial-hospital-pet-production/755cb4e5-752d-48d3-8f05-d44ef576276a

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