# FDA 483 - SOFIE Co. dba SOFIE - June 12, 2026

Source: https://www.keypedia.com/records/483/sofie-co-dba-sofie/29b81107-9eef-4274-ae1e-3ec3548b6641

> FDA 483 for SOFIE Co. dba SOFIE on June 12, 2026. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: SOFIE Co. dba SOFIE
- Inspection Date: 2026-06-12
- Product Type: drugs
- Office Name: Florida District Office
- Summary: SOFIE Co dba Sofie, a PET Drug Manufacturer in Miami Lakes, FL, was cited for significant deficiencies during a pre-approval inspection. Observations included failures in component identity testing, inadequate aseptic processing techniques by personnel, and a lack of robust quality assurance procedures. The firm also demonstrated insufficient production and process controls to ensure consistent drug product quality.

## Related Officers

- [Adetutu M. Gidado](https://www.keypedia.com/people/adetutu-m-gidado/6c4e8cf3-0eea-4903-9ca5-e8e2d683621d)

Company: https://www.keypedia.com/companies/sofie-co-dba-sofie/92bb48d1-7559-4768-85cb-fae6e9b47e18

Office: https://www.keypedia.com/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9