# FDA 483 - Maude Group Inc. - March 13, 2020

Source: https://www.globalkeysolutions.net/records/483/maude-group-inc/7a508859-08e8-4a63-a226-4f8064ef66e3

> FDA 483 for Maude Group Inc. on March 13, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Maude Group Inc.
- Inspection Date: 2020-03-13
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Maude Group Inc., a manufacturer in Brooklyn, NY, revealed significant deficiencies in its quality system. The firm failed to establish written procedures for critical operations including complaint handling, supplier management, incoming product acceptance, internal quality audits, and management review. These findings indicate a fundamental lack of basic quality system controls.

## Related Officers

- [Andrew J. Garufi](https://www.globalkeysolutions.net/people/andrew-j-garufi/567f6aaa-f6f2-45a3-9a58-80b33f3ad021)

Company: https://www.globalkeysolutions.net/companies/maude-group-inc/0602c1a5-2646-4bcd-8c14-8ca44cc19b4c

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