# FDA 483 - SOFIE Co. dba SOFIE - February 05, 2019

Source: https://www.keypedia.com/records/483/sofie-co-dba-sofie/6786adeb-bf02-41a7-9ec6-bdef4cfaa592

> FDA 483 for SOFIE Co. dba SOFIE on February 05, 2019. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: SOFIE Co. dba SOFIE
- Inspection Date: 2019-02-05
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: An FDA inspection of SOFIE Co. dba SOFIE, a PET drug manufacturer in Gilroy, CA, revealed significant deficiencies in quality assurance procedures, facility contamination control, personnel training, and laboratory record-keeping. The firm failed to ensure proper batch release authorization, maintain adequate cleaning records for critical equipment, provide representative aseptic processing training, and accurately document laboratory test performers.

## Related Documents

- [483 - 2025-08-07](https://www.keypedia.com/records/483/sofie-co-dba-sofie/9eb8efa4-a0b0-4e3b-bab5-9563b9e26401)

## Related Officers

- [National Program Expert- Pharmacy Compounding](https://www.keypedia.com/people/lucila-b-nwatu/3d1c9670-8206-425c-bddd-32e395293042)

Company: https://www.keypedia.com/companies/sofie-co-dba-sofie/de6e4fc3-a200-409d-86c0-bf24858b7004

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b