# FDA 483 - Lazurite Inc. - February 07, 2025

Source: https://www.keypedia.com/records/483/lazurite-inc/e511c321-3f41-4770-bd43-1b72b9dfa9c5

> FDA 483 for Lazurite Inc. on February 07, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lazurite Inc.
- Inspection Date: 2025-02-07
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: An FDA inspection of Lazurite Inc., a medical device manufacturer in Cleveland, OH, revealed significant deficiencies across its quality system. The firm was cited for inadequate risk analysis, poorly documented design input requirements, and insufficient design validation procedures. Additionally, issues were found with supplier control and procedures for handling nonconforming products, indicating a broad need for quality system improvements.

## Related Officers

- [Investigator ](https://www.keypedia.com/people/laureen-m-geniusz/759a858e-e3f3-4c48-8194-9804c7ab2a7b)

Company: https://www.keypedia.com/companies/lazurite-inc/e8bc21ea-a163-4af7-bd27-00a071256f5e

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22