# FDA 483 - Maco Bag - October 13, 2022

Source: https://www.keypedia.com/records/483/maco-bag/d2f6158d-818b-4af0-a8ba-afafd6426ba8

> FDA 483 for Maco Bag on October 13, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Maco Bag
- Inspection Date: 2022-10-13
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Maco Bag in Newark, NY, a medical device manufacturer, revealed significant deficiencies in its quality system. The firm failed to establish written Medical Device Reporting (MDR) procedures, adequately implement corrective and preventive action (CAPA) procedures, and prevent product contamination. These issues indicate a lack of control over critical manufacturing processes and quality management.

## Related Officers

- [investigator](https://www.keypedia.com/people/wendy-m-stone/715b04f5-3949-4ca6-9bda-26ff611e9354)

Company: https://www.keypedia.com/companies/maco-bag/0e0971a8-a06f-4f9f-86b5-81a0ff74ba76

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961