# FDA 483 - Intarcia Therapeutics, Inc. - January 17, 2020

Source: https://www.keypedia.com/records/483/intarcia-therapeutics-inc/de976a2c-32f1-40dd-8fd1-fff55bb8be85

> FDA 483 for Intarcia Therapeutics, Inc. on January 17, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Intarcia Therapeutics, Inc.
- Inspection Date: 2020-01-17
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: The FDA inspected Intarcia Therapeutics, Inc. in Hayward, CA, a drug manufacturer, and identified significant deficiencies. The inspection revealed repeated issues in aseptic processing, laboratory controls, and production controls, indicating a lack of adequate systems to ensure drug product quality and sterility. These observations highlight critical failures in process validation, environmental monitoring, and equipment maintenance, posing potential risks to product integrity.

## Related Officers

- [Chaochun J Wang](https://www.keypedia.com/people/chaochun-j-wang/7527198a-6003-4db5-b81c-096f99f650fc)
- [Consumer Safety Officer](https://www.keypedia.com/people/jeffrey-p-raimondi/7576ca4e-d9e8-4015-9ae6-9498e76058d3)
- [Uttaniti Limchumroon](https://www.keypedia.com/people/uttaniti-limchumroon/ce890cbf-2f5c-498f-917c-0edf8b10d356)
- [Souree Gangorli](https://www.keypedia.com/people/souree-gangorli/e3c6d7d7-19c8-478b-a8e8-2736e160b2e7)

Company: https://www.keypedia.com/companies/intarcia-therapeutics-inc/e37484a6-8e78-4d81-ade5-e94a83eb2a12

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