# FDA 483 - Crane Dental Laboratory, Inc. - September 01, 2022

Source: https://www.globalkeysolutions.net/records/483/crane-dental-laboratory-inc/8c9df410-d515-4597-8996-ee5c08a84e22

> FDA 483 for Crane Dental Laboratory, Inc. on September 01, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Crane Dental Laboratory, Inc.
- Inspection Date: 2022-09-01
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Crane Dental Laboratory, Inc., a medical device manufacturer in Rochester, NY, revealed significant deficiencies in their quality system. The firm was cited for inadequate procedures related to design validation, nonconforming product control, corrective and preventive actions, and design requirements. These issues indicate a need for comprehensive improvements in their quality management processes.

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- [483 - 2025-08-05](https://www.globalkeysolutions.net/records/483/crane-dental-laboratory-inc/50b06144-08a4-4fac-a38e-3da1994a043a)

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/crane-dental-laboratory-inc/d91e045e-0032-4e7b-a324-1e4c8117ed19

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