# FDA 483 - Celestica Oregon, LLC. - October 25, 2019

Source: https://www.keypedia.com/records/483/celestica-oregon-llc/4666dab3-25ce-4aea-9764-3eafb7eea654

> FDA 483 for Celestica Oregon, LLC. on October 25, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Celestica Oregon, LLC.
- Inspection Date: 2019-10-25
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: Celestica Oregon, LLC, a contract manufacturer of Class II medical devices for ECG monitoring in Portland, OR, was cited for significant deficiencies in its quality system. The inspection revealed inadequate procedures for handling customer complaints, specifically lacking documentation for complaint investigations and device history record reviews. Additionally, the firm failed to adequately establish procedures for device history records, with multiple DHRs missing required identification and labeling elements.

## Related Officers

- [investigator](https://www.keypedia.com/people/christopher-s-genther/e71df42c-9adf-4a78-93e5-c364dcc06b35)

Company: https://www.keypedia.com/companies/celestica-oregon-llc/451c59b9-81ed-4453-91f5-76f4ec288dd7

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-vi/6e5a2a08-f464-4979-a759-7b0383370822