# FDA 483 - Orthodent Laboratory, Inc. - March 24, 2021

Source: https://www.globalkeysolutions.net/records/483/orthodent-laboratory-inc/1b39cdfc-657c-497e-962f-767aae5e0b8b

> FDA 483 for Orthodent Laboratory, Inc. on March 24, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Orthodent Laboratory, Inc.
- Inspection Date: 2021-03-24
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Orthodent Laboratory, Inc. in Buffalo, NY, a medical device manufacturer, was inspected by the FDA from March 22-24, 2021. The inspection revealed significant deficiencies across its quality system, particularly concerning the manufacture of Vivid Aligners. Key issues included inadequate device master and history records, unvalidated processes and software, insufficient supplier controls, and failures in product acceptance, CAPA, nonconforming product, equipment maintenance, personnel training, and document control.

## Related Documents

- [EIR - 2021-03-24](https://www.globalkeysolutions.net/records/eir/orthodent-laboratory-inc/c4f1684d-f2dd-470c-b8ff-e40b98b36f6c)
- [483 - 2023-11-13](https://www.globalkeysolutions.net/records/483/orthodent-laboratory-inc/fd9bea80-79a8-46fe-a695-cd171d7a09ef)

## 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