# FDA 483 - MEDLINE INDUSTRIES, LP - Northfield - January 22, 2024

Source: https://www.keypedia.com/records/483/medline-industries-lp-northfield/645298bf-de08-4ee8-b52e-86f8f60e12ba

> FDA 483 for MEDLINE INDUSTRIES, LP - Northfield on January 22, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: MEDLINE INDUSTRIES, LP - Northfield
- Inspection Date: 2024-01-22
- Product Type: device
- Office Name: Chicago District Office
- Summary: This FDA Form 483 report for MEDLINE INDUSTRIES, LP - Northfield details significant deficiencies across multiple quality system areas. The firm failed to adequately establish and follow procedures for Medical Device Reporting, complaint handling, design changes, corrective and preventive actions, and control of purchased products. These issues indicate a systemic breakdown in ensuring device safety, quality, and regulatory compliance, with one observation being a repeat finding.

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## Related Officers

- [Natasha R. Johnson](https://www.keypedia.com/people/natasha-r-johnson/ae9e5ea3-74dd-427e-9f8b-32faa975679e)
- [investigator](https://www.keypedia.com/people/michelle-j-glembin/e58f4652-d09f-41a7-941d-335c7b5338ad)

Company: https://www.keypedia.com/companies/medline-industries-lp-northfield/74baddeb-3a7b-4ee5-9901-7de833db2440

Office: https://www.keypedia.com/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669