# FDA 483 - Tandem Diabetes Care, Inc. - December 23, 2014

Source: https://www.keypedia.com/records/483/tandem-diabetes-care-inc/0791c40a-d5a9-4bc7-9203-6b1ef0aa6b30

> FDA 483 for Tandem Diabetes Care, Inc. on December 23, 2014. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Tandem Diabetes Care, Inc.
- Inspection Date: 2014-12-23
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Tandem Diabetes Care Inc, a medical device manufacturer in San Diego, CA, revealed multiple deficiencies in their quality system. Observations included inadequately approved process validation activities, poorly established process control procedures, and uncontrolled production processes. Additionally, the firm lacked adequate procedures for monitoring process parameters and schedules for equipment maintenance.

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## Related Officers

- [Scott K. Zika](https://www.keypedia.com/people/scott-k-zika/7f967edd-5151-438b-a0e7-dd1db8a227d1)

Company: https://www.keypedia.com/companies/tandem-diabetes-care-inc/55c8bf38-f959-46dd-8954-5ac3480bea3e

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