# FDA 483 - ULab Systems, Inc. - July 23, 2019

Source: https://www.keypedia.com/records/483/ulab-systems-inc/c349f650-2929-41ae-a824-83e32091c802

> FDA 483 for ULab Systems, Inc. on July 23, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ULab Systems, Inc.
- Inspection Date: 2019-07-23
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: ULab Systems, Inc., a medical device manufacturer in Redwood City, CA, was cited for deficiencies in its complaint handling system. The inspection revealed that the firm failed to review, evaluate, and investigate device failure complaints in a timely manner. Multiple UDesign Software complaints remained open without any root cause investigations, indicating a significant lapse in their quality system.

## Related Officers

- [investigator](https://www.keypedia.com/people/sarah-a-hassas/4f142d54-fc28-4bd5-82ad-7e6fa443688c)

Company: https://www.keypedia.com/companies/ulab-systems-inc/bb9128d0-4c51-43a5-88f9-084f8d631a70

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