# FDA 483 - SOFIE Co. dba SOFIE - April 21, 2026

Source: https://www.keypedia.com/records/483/sofie-co-dba-sofie/e4a6150c-e487-420b-8003-a7ebb9a632f4

> FDA 483 for SOFIE Co. dba SOFIE on April 21, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SOFIE Co. dba SOFIE
- Inspection Date: 2026-04-21
- Product Type: drugs
- Office Name: Dallas District Office
- Summary: An FDA inspection of SOFIE Co. dba SOFIE in Dallas, TX, a PET drug manufacturer, identified a significant deficiency related to equipment cleaning and suitability. The firm failed to implement and document procedures to ensure equipment, specifically a hot cell, was properly maintained and cleaned. This lapse creates a contamination risk for materials used in aseptic operations.

## Related Officers

- [Youkeun Kim](https://www.keypedia.com/people/youkeun-kim/94ccfde4-72f7-4df1-9c68-ede73e5e23d0)

Company: https://www.keypedia.com/companies/sofie-co-dba-sofie/3b677367-baec-43c5-8387-5939b730d8b7

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9