# FDA 483 - Metropolis International LLC - February 28, 2020

Source: https://www.globalkeysolutions.net/records/483/metropolis-international-llc/6c03bcf7-2898-4b6f-8741-5bf338b15e45

> FDA 483 for Metropolis International LLC on February 28, 2020. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Metropolis International LLC
- Inspection Date: 2020-02-28
- Product Type: other
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Metropolis International LLC, a manufacturer in Long Island City, NY, revealed significant deficiencies in their quality system. Observations included a lack of documented equipment calibrations, undeveloped written Medical Device Reporting (MDR) procedures, and unestablished procedures for corrective and preventive actions. Notably, the issues regarding MDR and CAPA procedures were repeat observations from a previous inspection.

## Related Documents

- [483 - 2023-01-27](https://www.globalkeysolutions.net/records/483/metropolis-international-llc/cc27b944-106e-43fd-8912-56cbbd89aaf4)

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/metropolis-international-llc/8b50f1d0-435e-482b-b6d7-8e6ce74d5ed9

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