483
Lazurite Inc.Lazurite Inc. – FDA 483, Feb 7, 2025
Record Details
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.
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ID · e511c321-3f41-4770-bd43-1b72b9dfa9c5
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