# FDA 483 - Formulation Technology, Inc. - March 21, 2025

Source: https://www.keypedia.com/records/483/formulation-technology-inc/d454ccf6-c90b-4ed0-ac03-a344f8a633ab

> FDA 483 for Formulation Technology, Inc. on March 21, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Formulation Technology, Inc.
- Inspection Date: 2025-03-21
- Product Type: drugs
- Office Name: San Francisco District Office
- Summary: An FDA inspection of Formulation Technology, Inc. in Oakdale, CA, a dietary supplement and drug manufacturer, revealed significant deficiencies across multiple areas of its operations. The firm failed to implement effective contamination prevention measures, exhibited poor quality control unit oversight, and neglected proper equipment calibration and maintenance. Additionally, widespread employee training failures were noted, indicating a serious lack of adherence to current Good Manufacturing Practices.

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- [483 - 2020-01-10](https://www.keypedia.com/records/483/formulation-technology-inc/8d32d4dc-d6e5-4a3a-8b24-5671f0ff4e09)
- [483 - 2023-11-09](https://www.keypedia.com/records/483/formulation-technology-inc/14adb049-a8aa-4515-be12-252940d2fabb)
- [WARNING_LETTER - 2023-11-09](https://www.keypedia.com/records/warning_letter/formulation-technology-inc/94196fbd-3041-4a03-ad92-73292b20f9f3)

## Related Officers

- [Jennifer Crumb](https://www.keypedia.com/people/jennifer-crumb/ab32d911-b850-4ac2-8603-603eb5f44a48)
- [Stryker, Regulatory Affairs](https://www.keypedia.com/people/gunneet-kaur/e2823ed9-44f2-4553-8984-895ef8c7eece)

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

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