# FDA 483 - GlobalMed Inc. - April 27, 2023

Source: https://www.globalkeysolutions.net/records/483/globalmed-inc/6991c547-7921-44c5-8bb3-00050723d7a8

> FDA 483 for GlobalMed Inc. on April 27, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: GlobalMed Inc.
- Inspection Date: 2023-04-27
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: GlobalMed Inc., a medical device contract manufacturer in Trenton, received a Form FDA 483 with four observations during an inspection from April 24-27, 2023. The inspection identified deficiencies in process validation, corrective and preventive action procedures, incoming product acceptance, and equipment maintenance schedules. These issues indicate a need for improved quality system controls at the facility.

## Related Officers

- [Matthew D. Schnittker](https://www.globalkeysolutions.net/people/matthew-d-schnittker/cf76f07f-db6d-47a0-8412-7eb084d4fe8b)

Company: https://www.globalkeysolutions.net/companies/globalmed-inc/2434eae5-2b49-45ec-a153-b621e5819e3c

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd