# FDA 483 - Dentaline LLC - July 29, 2021

Source: https://www.globalkeysolutions.net/records/483/dentaline-llc/75b5159d-0e22-4fb6-bbdb-c20276c66160

> FDA 483 for Dentaline LLC on July 29, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dentaline LLC
- Inspection Date: 2021-07-29
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Dentaline LLC, a medical device importer in Brooklyn, NY, received two observations during an FDA inspection. The firm was cited for not having written procedures for Medical Device Reporting (MDR), including electronic MDR and an Electronic Submissions Gateway account. Additionally, the inspection found a lack of established procedures for corrective and preventive actions (CAPA) related to medical device investigations.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/dentaline-llc/04aa4414-7853-40cf-b62c-7c86eff43ad3

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