# FDA 483 - Roche Diabetes Care, Inc. - July 25, 2019

Source: https://www.globalkeysolutions.net/records/483/roche-diabetes-care-inc/8eef2a9f-44ae-49ed-8071-98d08d894d1c

> FDA 483 for Roche Diabetes Care, Inc. on July 25, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Roche Diabetes Care, Inc.
- Inspection Date: 2019-07-25
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: Roche Diabetes Care, Inc. in Indianapolis, IN, was issued a Form FDA 483 following an inspection from July 15-25, 2019, citing three observations. The firm failed to adequately validate a process related to a debris detection system and did not maintain complete supporting data or updated specifications. Significant deficiencies were also noted in corrective and preventive action (CAPA) procedures, including lack of effectiveness verification and numerous overdue tasks. Additionally, process control procedures for cleaning and preventive maintenance were not adequately established.

## Related Officers

- [Debara R. Reese](https://www.globalkeysolutions.net/people/debara-r-reese/277a8fbb-ba4d-4402-be08-16d7977685db)

Company: https://www.globalkeysolutions.net/companies/roche-diabetes-care-inc/2a2a4a45-f982-46b0-96c1-4e8f08a6bc86

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0