# FDA 483 - SOFIE Co. dba SOFIE - August 07, 2025

Source: https://www.keypedia.com/records/483/sofie-co-dba-sofie/9eb8efa4-a0b0-4e3b-bab5-9563b9e26401

> FDA 483 for SOFIE Co. dba SOFIE on August 07, 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: 2025-08-07
- Product Type: drugs
- Office Name: San Francisco District Office
- Summary: SOFIE Co. dba SOFIE in Gilroy, CA, a PET drug manufacturer, was inspected and received a Form 483 with three observations. The inspection revealed significant deficiencies in equipment cleaning and sanitization procedures, inadequate batch release processes lacking verification of pre-production cleaning and electronic data review, and issues with personnel training record management. These findings indicate a moderate level of non-compliance with GMP regulations.

## Related Documents

- [483 - 2019-02-05](https://www.keypedia.com/records/483/sofie-co-dba-sofie/6786adeb-bf02-41a7-9ec6-bdef4cfaa592)

## Related Officers

- [Consumer Safety Officer (Inspector)](https://www.keypedia.com/people/christopher-r-czajka/42defbf3-ea06-4090-8d51-7da2b07d9e84)

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

Office: https://www.keypedia.com/offices/san-francisco-district-office/6f838e9c-aae1-4665-9c46-a51d43be02df