# FDA 483 - MEDLINE INDUSTRIES, LP - Northfield - August 29, 2025

Source: https://www.keypedia.com/records/483/medline-industries-lp-northfield/9461f9e5-9651-4aab-8172-dd9ed710cd05

> FDA 483 for MEDLINE INDUSTRIES, LP - Northfield on August 29, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: MEDLINE INDUSTRIES, LP - Northfield
- Inspection Date: 2025-08-29
- Product Type: device
- Office Name: Chicago District Office
- Summary: Medline Industries, LP, a medical device manufacturer in Northfield, IL, received a Form FDA 483 citing significant quality system deficiencies. The inspection revealed inadequate corrective and preventive action procedures, insufficient control over purchased products, and failures in Medical Device Report (MDR) submission for serious injuries, including a death. Additionally, the firm's complaint handling and nonconforming product control processes were found to be deficient, leading to multiple product recalls and patient safety concerns.

## Related Documents

- [483 - 2022-04-06](https://www.keypedia.com/records/483/medline-industries-lp-northfield/10da5c10-cea7-4586-a9e8-bd165d180dea)
- [483 - 2024-01-22](https://www.keypedia.com/records/483/medline-industries-lp-northfield/645298bf-de08-4ee8-b52e-86f8f60e12ba)

## Related Officers

- [Edward E. Lockwood](https://www.keypedia.com/people/edward-e-lockwood/3260b39e-9211-489f-8247-0ec3353e57ca)
- [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