# FDA 483 - Medicrea USA Corp - November 21, 2019

Source: https://www.keypedia.com/records/483/medicrea-usa-corp/314b7a0a-068a-41f9-87f9-7cff12db4a83

> FDA 483 for Medicrea USA Corp on November 21, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Medicrea USA Corp
- Inspection Date: 2019-11-21
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Med-Area USA Corp in New York, NY, a medical device repackager and importer, revealed significant deficiencies in their quality system. Observations included inadequate Medical Device Reporting (MDR) procedures, poorly maintained complaint files, and the use of obsolete documents. Additionally, production processes were not adequately controlled to ensure device conformity.

## Related Officers

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

Company: https://www.keypedia.com/companies/medicrea-usa-corp/5115c309-11b8-49d3-b5f5-2c553a4d6a60

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