# FDA 483 - Nordson Medical Design and Development, Inc. - October 31, 2023

Source: https://www.keypedia.com/records/483/nordson-medical-design-and-development-inc/d2ad0723-0dcd-4774-b35a-1beb7147ffc8

> FDA 483 for Nordson Medical Design and Development, Inc. on October 31, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Nordson Medical Design and Development, Inc.
- Inspection Date: 2023-10-31
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: Nordson Medical Design and Development, Inc. in San Jose, CA, a contract device manufacturer, received two observations during an FDA inspection. The firm was cited for failing to validate a cleaning process for a medical device and for not having adequately established procedures to prevent contamination during material transfer into a controlled environment room. These findings indicate deficiencies in process validation and contamination control practices.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/yubing-tang/3338f3f3-6457-48b8-86e2-97893282d2ef)
- [Consumer Safety Officer (Inspector)](https://www.keypedia.com/people/christopher-r-czajka/42defbf3-ea06-4090-8d51-7da2b07d9e84)

Company: https://www.keypedia.com/companies/nordson-medical-design-and-development-inc/a9096502-6fc9-46d8-8b24-ede508ec3a84

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