# FDA 483 - Formulation Technology, Inc. - November 09, 2023

Source: https://www.keypedia.com/records/483/formulation-technology-inc/14adb049-a8aa-4515-be12-252940d2fabb

> FDA 483 for Formulation Technology, Inc. on November 09, 2023. Product: other. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Formulation Technology, Inc.
- Inspection Date: 2023-11-09
- Product Type: other
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: Formulation Technology, Inc. in Oakdale, CA, a dietary supplement manufacturer, received a Form 483 for significant deficiencies in their quality control and specification establishment. The inspection revealed failures to establish adequate identity, purity, strength, and composition specifications for both components and finished products, along with a lack of contamination limits. Additionally, quality control personnel failed to properly approve or reject specifications, indicating systemic issues in their quality system.

## Related Documents

- [483 - 2020-01-10](https://www.keypedia.com/records/483/formulation-technology-inc/8d32d4dc-d6e5-4a3a-8b24-5671f0ff4e09)
- [WARNING_LETTER - 2023-11-09](https://www.keypedia.com/records/warning_letter/formulation-technology-inc/94196fbd-3041-4a03-ad92-73292b20f9f3)
- [483 - 2025-03-21](https://www.keypedia.com/records/483/formulation-technology-inc/d454ccf6-c90b-4ed0-ac03-a344f8a633ab)

## Related Officers

- [Yen-Tso Kuo](https://www.keypedia.com/people/yen-tso-kuo/1d2b4e33-285b-439b-b8c3-cfbed6ff4621)
- [Sparky L Bartee](https://www.keypedia.com/people/sparky-l-bartee/d47e1703-b88e-409b-aaba-29b4c38545ef)

Company: https://www.keypedia.com/companies/formulation-technology-inc/38721a36-c9d0-44b1-ad0f-4dd20d8139d1

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