# FDA 483 - Sol-ti, Inc. - February 08, 2023

Source: https://www.keypedia.com/records/483/sol-ti-inc/b5605743-51f9-4830-95d8-86bf4c6d2004

> FDA 483 for Sol-ti, Inc. on February 08, 2023. Product: other. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Sol-ti, Inc.
- Inspection Date: 2023-02-08
- Product Type: other
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Sol-ti Inc. in San Diego, CA, a juice manufacturer, was cited for significant deficiencies in its HACCP plan validation, hazard analysis, monitoring procedures, and sanitation practices for juice products. Additionally, the inspection revealed a lack of established quality control procedures, component and finished product specifications, and proper manufacturing records for its dietary supplement products. These issues indicate a broad failure to adhere to good manufacturing practices and ensure product safety and quality.

## Related Documents

- [WARNING_LETTER - 2023-02-08](https://www.keypedia.com/records/warning_letter/sol-ti-inc/5a8c23eb-4dc6-4cfc-9620-8fbaf610aaa1)
- [483 - 2023-10-05](https://www.keypedia.com/records/483/sol-ti-inc/a51ef12a-b68e-4033-964f-acb0d99f44d8)

## Related Officers

- [Mary C. Wall](https://www.keypedia.com/people/mary-c-wall/c676a538-9abc-4625-886d-e7a70f902ddd)
- [Sparky L Bartee](https://www.keypedia.com/people/sparky-l-bartee/d47e1703-b88e-409b-aaba-29b4c38545ef)

Company: https://www.keypedia.com/companies/sol-ti-inc/a7d82d87-da2a-499d-9039-357a1aa4e9cb

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6