# FDA 483 - Mak Healthcare Inc - February 26, 2019

Source: https://www.globalkeysolutions.net/records/483/mak-healthcare-inc/85d7a369-c232-4af5-9778-318d966e98d9

> FDA 483 for Mak Healthcare Inc on February 26, 2019. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Mak Healthcare Inc
- Inspection Date: 2019-02-26
- Product Type: device
- Office Name: Chicago District Office
- Summary: An FDA inspection of Mak Healthcare Inc in Schaumburg, IL, an initial importer and device refurbisher, revealed a significant lack of established quality system procedures. The firm failed to implement formal processes for complaint handling, purchasing controls, and a general quality policy. This indicates fundamental deficiencies in their quality management system.

## Related Officers

- [Medical Device Specialist](https://www.globalkeysolutions.net/people/jesse-a-vazquez/cac5b170-d0ea-4355-af5d-3d81546ff0fe)

Company: https://www.globalkeysolutions.net/companies/mak-healthcare-inc/8edd3770-0c73-4130-97a5-2e2c167b3da6

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