# FDA 483 - Medline Industries, LP - May 25, 2018

Source: https://www.globalkeysolutions.net/records/483/medline-industries-lp/cef6dde0-c65e-46ca-85c1-07bd5417e2e5

> FDA 483 for Medline Industries, LP on May 25, 2018. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Medline Industries, LP
- Inspection Date: 2018-05-25
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West I
- Summary: An FDA inspection of Medline Industries, Inc. in Hartland, WI, from May 22-25, 2018, revealed significant deficiencies in their manufacturing practices. Observations included inadequate environmental monitoring procedures, insufficient out-of-specification investigation processes, and a lack of appropriate controls over computer systems used for identity testing. These issues indicate a need for improved quality control and data integrity measures at the facility.

## Related Documents

- [483 - 2025-07-18](https://www.globalkeysolutions.net/records/483/medline-industries-lp/bdf967be-520a-457a-b806-c5478984f486)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/andrew-j-idzior/5b639c02-d062-4a5a-aa4a-8362ddfba2b6)
- [Ross J. Grigsby](https://www.globalkeysolutions.net/people/ross-j-grigsby/713f8252-3e41-4e6f-abea-8ca5bd48aa83)

Company: https://www.globalkeysolutions.net/companies/medline-industries-lp/734698ca-f714-4f20-90e6-4542258ff970

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-i/1c3129a0-b8fd-4558-9283-44531498dbdd