# FDA 483 - Formulation Technology, Inc. - January 10, 2020

Source: https://www.keypedia.com/records/483/formulation-technology-inc/8d32d4dc-d6e5-4a3a-8b24-5671f0ff4e09

> FDA 483 for Formulation Technology, Inc. on January 10, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Formulation Technology, Inc.
- Inspection Date: 2020-01-10
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: An FDA inspection of Formulation Technology, Inc. in Oakdale, CA, revealed significant deficiencies in data integrity and quality control for their drug manufacturing operations. The firm failed to implement appropriate controls for computer systems used in potency testing, leading to unverified data. Additionally, the Quality Control Unit did not follow established procedures for product quality reviews and preventative maintenance for manufacturing equipment.

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## Related Officers

- [Scott N. Lim](https://www.keypedia.com/people/scott-n-lim/d5e7745a-d804-48d1-8f3b-a94a8d4aed8a)

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