# FDA 483 - Blue Chip Medical Products, Inc. - March 18, 2019

Source: https://www.globalkeysolutions.net/records/483/blue-chip-medical-products-inc/724d1aa4-4ba2-4e04-8c3b-a75a7ca5c07c

> FDA 483 for Blue Chip Medical Products, Inc. on March 18, 2019. 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: 2019-03-18
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: This FDA Form 483 was issued to Blue Chip Medical Products, Inc. in Suffern, NY, following an inspection on March 18, 2019. The inspection revealed significant deficiencies in the firm's quality system, specifically the absence of written procedures for Medical Device Reporting (MDR) and corrective and preventive actions (CAPA). These observations indicate fundamental gaps in the firm's regulatory compliance.

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- [483 - 2022-02-18](https://www.globalkeysolutions.net/records/483/blue-chip-medical-products-inc/a8c75c36-78c9-41d1-9d5f-7cf5ce8df41a)

## Related Officers

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

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