# FDA 483 - Sofie Co dba Sofie - July 25, 2025

Source: https://www.keypedia.com/records/483/sofie-co-dba-sofie/0e9fc79b-32b0-4058-9e3d-e696ea17120f

> FDA 483 for Sofie Co dba Sofie on July 25, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sofie Co dba Sofie
- Inspection Date: 2025-07-25
- Product Type: drugs
- Office Name: Baltimore District Office
- Summary: An FDA inspection of Sofie Co dba Sofie, a PET Drug Manufacturer in Sterling, VA, revealed a critical failure in quality control. The firm did not conduct appropriate laboratory determinations to ensure PET drug products met specifications before release. This included inadequate investigations into out-of-specification bacterial endotoxin results, unauthorized retesting, and the release of affected batches without proper confirmatory testing.

## Related Documents

- [483 - 2018-12-03](https://www.keypedia.com/records/483/sofie-co-dba-sofie/3465ef16-1bcf-4612-afe1-248b0baa6812)

## Related Officers

- [Pharmacy Intern/Certified Pharmacy Technician](https://www.keypedia.com/people/david-a-oluwo/209d60bd-27d8-487b-8249-1c6e44fcc317)
- [other](https://www.keypedia.com/people/kelly-i-anderson/a57b8330-d56e-4e71-bb34-fe7bef0e31dc)

Company: https://www.keypedia.com/companies/sofie-co-dba-sofie/4c07e010-a465-4c86-b712-d1ee6e051f30

Office: https://www.keypedia.com/offices/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa