# FDA 483 - Metropolis International LLC - January 27, 2023

Source: https://www.keypedia.com/records/483/metropolis-international-llc/cc27b944-106e-43fd-8912-56cbbd89aaf4

> FDA 483 for Metropolis International LLC on January 27, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Metropolis International LLC
- Inspection Date: 2023-01-27
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Metropolis International LLC, a medical device refurbisher in Long Island City, NY, received a Form FDA 483 with four observations during an inspection. The firm was cited for significant deficiencies in its quality system, specifically regarding the lack of established procedures and adequate documentation for complaint handling, corrective and preventive actions (CAPA), and process controls for refurbished devices.

## Related Documents

- [483 - 2020-02-28](https://www.keypedia.com/records/483/metropolis-international-llc/6c03bcf7-2898-4b6f-8741-5bf338b15e45)

## Related Officers

- [investigator](https://www.keypedia.com/people/kwong-p-lee/f4778925-1fad-4988-9e39-86482896c4fa)

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

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