# FDA 483 - ImaCor Inc. - June 10, 2021

Source: https://www.keypedia.com/records/483/imacor-inc/96fdb3c5-f8db-4aa9-9413-ad30ff349d9e

> FDA 483 for ImaCor Inc. on June 10, 2021. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: ImaCor Inc.
- Inspection Date: 2021-06-10
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: ImaCor Inc., a medical device manufacturer in Jericho, NY, was inspected by the FDA, revealing significant deficiencies in their quality system. The inspection found that the firm failed to maintain written Medical Device Reporting (MDR) procedures, inadequately maintained complaint files, and lacked proper documentation of approval for critical documents. These issues indicate a need for improved adherence to regulatory requirements for medical device manufacturing.

## Related Officers

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

Company: https://www.keypedia.com/companies/imacor-inc/34bca216-5481-4e9a-8163-aa020aceb0d4

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