# FDA 483 - Medline Industries, Inc - May 22, 2018

Source: https://www.globalkeysolutions.net/records/483/medline-industries-inc/6382f890-316f-4a44-8a77-d840dbc38e8e

> FDA 483 for Medline Industries, Inc on May 22, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Medline Industries, Inc
- Inspection Date: 2018-05-22
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West I
- Summary: An FDA inspection of Medline Industries, Inc.'s Control Laboratory in Mundelein, IL, revealed two observations. The firm lacked appropriate controls over computer systems to prevent unauthorized data deletion and did not have procedures for reviewing audit trails. Additionally, laboratory controls were found to be deficient, specifically regarding a test method used for stability testing that did not specify the calculation of unspecified impurities.

## 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-inc/8a6959ab-49ef-4908-a7d7-c34bf8028d1c

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