# FDA 483 - Mak-System Corp. - August 11, 2023

Source: https://www.keypedia.com/records/483/mak-system-corp/48dbd28d-32e7-48c4-ace0-d92bf83a9029

> FDA 483 for Mak-System Corp. on August 11, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Mak-System Corp.
- Inspection Date: 2023-08-11
- Product Type: biologics
- Office Name: Chicago District Office
- Summary: An FDA inspection of Mak-System Corp. in Des Plaines, IL, a manufacturer and initial importer of ePROGESA blood bank software, revealed significant deficiencies in its quality system. The firm was cited for inadequate procedures for complaint handling, which was a repeat observation, and for failing to adequately establish and document corrective and preventive actions. These issues indicate a systemic lack of rigor in managing quality processes.

## Related Officers

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

Company: https://www.keypedia.com/companies/mak-system-corp/7fadbd95-9e72-4d4e-aec3-7ef67f463ff6

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