# FDA 483 - Sofie Co dba Sofie - December 03, 2018

Source: https://www.keypedia.com/records/483/sofie-co-dba-sofie/3465ef16-1bcf-4612-afe1-248b0baa6812

> FDA 483 for Sofie Co dba Sofie on December 03, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sofie Co dba Sofie
- Inspection Date: 2018-12-03
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: Sofie Co dba Sofie in Sterling, VA, a PET drug manufacturer, received a Form 483 with three observations. The inspection revealed inadequate facilities for contamination prevention, failure to submit required NDA-Field Alert Reports for distributed drug products, and non-adherence to written quality assurance procedures regarding annual product reviews. These issues indicate potential risks to product quality and regulatory non-compliance.

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## Related Officers

- [Mindy M. Chou](https://www.keypedia.com/people/mindy-m-chou/3d0e74bf-ad6b-48b5-8b72-cbb29e9c9ce5)

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

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-ii/a9ab7e08-db36-4350-a7d7-6a61dc61250e