483
Crane Dental Laboratory, Inc.Crane Dental Laboratory, Inc. – FDA 483, Sep 1, 2022
Record Details
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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ID · 8c9df410-d515-4597-8996-ee5c08a84e22
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