# FDA 483 - Orthodent Laboratory, Inc. - November 13, 2023

Source: https://www.globalkeysolutions.net/records/483/orthodent-laboratory-inc/fd9bea80-79a8-46fe-a695-cd171d7a09ef

> FDA 483 for Orthodent Laboratory, Inc. on November 13, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Orthodent Laboratory, Inc.
- Inspection Date: 2023-11-13
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Orthodent Laboratory, Inc. was inspected as a medical device manufacturer and received nine observations related to significant quality system deficiencies. The inspection revealed inadequate procedures for corrective and preventive actions, issues with Unique Device Identifier (UDI) labeling and database submission for Vivid Aligners, and insufficient process controls for manufacturing. Additionally, the firm failed to adequately document supplier monitoring, incoming product acceptance, software validation, device history records, and personnel training.

## Related Documents

- [EIR - 2021-03-24](https://www.globalkeysolutions.net/records/eir/orthodent-laboratory-inc/c4f1684d-f2dd-470c-b8ff-e40b98b36f6c)
- [483 - 2021-03-24](https://www.globalkeysolutions.net/records/483/orthodent-laboratory-inc/1b39cdfc-657c-497e-962f-767aae5e0b8b)

## Related Officers

- [Matthew D. Schnittker](https://www.globalkeysolutions.net/people/matthew-d-schnittker/cf76f07f-db6d-47a0-8412-7eb084d4fe8b)

Company: https://www.globalkeysolutions.net/companies/orthodent-laboratory-inc/9b8304f9-d206-4b2d-89a4-a029f14e1c72

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