# FDA 483 - Remote Technologies, Inc. - November 08, 2023

Source: https://www.globalkeysolutions.net/records/483/remote-technologies-inc/74da919d-97b9-4c46-a7f5-253e435dd2c6

> FDA 483 for Remote Technologies, Inc. on November 08, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Remote Technologies, Inc.
- Inspection Date: 2023-11-08
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Remote Technologies, Inc., a medical device manufacturer in Greenwich, CT, identified two significant observations. The firm failed to maintain written Medical Device Reporting (MDR) procedures, specifically lacking eMDR procedures and an Electronic Submissions Gateway (ESG) account. Additionally, the device master record was not adequately maintained, as it did not document the use of a specific tag for repair and rework operations.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/remote-technologies-inc/5a4dec1a-5d61-4557-9f86-cae599ec978b

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