# FDA 483 - Crane Dental Laboratory, Inc. - August 05, 2025

Source: https://www.keypedia.com/records/483/crane-dental-laboratory-inc/50b06144-08a4-4fac-a38e-3da1994a043a

> FDA 483 for Crane Dental Laboratory, Inc. on August 05, 2025. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Crane Dental Laboratory, Inc.
- Inspection Date: 2025-08-05
- Product Type: device
- Office Name: New York District Office
- Summary: An FDA inspection of Crane Dental Laboratory, Inc. in Rochester, NY, a manufacturer of dental devices, identified a significant issue with the maintenance of complaint files. The firm's procedures allowed for complaint closure without full review, and several reviewed complaints lacked complete investigation details. This indicates deficiencies in their quality system for handling customer complaints.

## Related Documents

- [483 - 2022-09-01](https://www.keypedia.com/records/483/crane-dental-laboratory-inc/8c9df410-d515-4597-8996-ee5c08a84e22)

## Related Officers

- [investigator](https://www.keypedia.com/people/wendy-m-stone/715b04f5-3949-4ca6-9bda-26ff611e9354)

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

Office: https://www.keypedia.com/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d