# FDA 483 - Blue Chip Medical Products, Inc. - February 18, 2022

Source: https://www.globalkeysolutions.net/records/483/blue-chip-medical-products-inc/a8c75c36-78c9-41d1-9d5f-7cf5ce8df41a

> FDA 483 for Blue Chip Medical Products, Inc. on February 18, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Blue Chip Medical Products, Inc.
- Inspection Date: 2022-02-18
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Blue Chip Medical Products, Inc. in Suffern, NY, revealed deficiencies in their quality system. The firm failed to maintain written Medical Device Reporting (MDR) procedures and lacked an electronic submission account. Additionally, critical standard operating procedures were not properly approved with dates and signatures from upper management.

## Related Documents

- [483 - 2019-03-18](https://www.globalkeysolutions.net/records/483/blue-chip-medical-products-inc/724d1aa4-4ba2-4e04-8c3b-a75a7ca5c07c)

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/blue-chip-medical-products-inc/94e54133-db47-42cc-be7f-e465cc0fe6f6

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