# FDA 483 - Sofie Co - July 09, 2024

Source: https://www.globalkeysolutions.net/records/483/sofie-co/d92e7a42-c22f-46c6-b665-90bf779188b1

> FDA 483 for Sofie Co on July 09, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sofie Co
- Inspection Date: 2024-07-09
- Product Type: drugs
- Office Name: Chicago District Office
- Summary: Sofie Co. dba Sofie, a human PET drug manufacturer in Romeoville, IL, was cited for significant deficiencies in equipment cleaning procedures and production/process controls during an FDA inspection. Observations included inadequate cleaning of laminar flow hoods, failure to adhere to disinfectant contact times, and critical aseptic processing breaches by personnel. These issues indicate a lack of control over the manufacturing environment and processes, potentially impacting drug quality and purity.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/gabriel-bermudez-picart/3263ce6e-a27d-4d4b-953c-4477c17aa182)
- [Consumer Safety Officer/ Federal Investigator](https://www.globalkeysolutions.net/people/lisa-l-flores/465a6807-55d7-4c3f-a415-c21ac4517bc9)
- [investigator](https://www.globalkeysolutions.net/people/chad-w-rice/b00f381a-744d-4e5e-90bf-07f60f494afc)

Company: https://www.globalkeysolutions.net/companies/sofie-co/fc1daee3-1aa5-428d-8ba6-f681f0d7d586

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