483
Desco Industries, Inc.FDA 483 - Desco Industries, Inc. - November 07, 2024
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Record Details
An FDA inspection of Desco Industries, Inc., a contract manufacturer in Chino, CA, revealed a significant issue with their finished device acceptance procedures. The firm failed to adequately establish and follow procedures for reviewing and documenting dose audit records, which are critical for Device History Records. This indicates a lapse in quality system controls related to product release.
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ID · e6defff5-e7e6-4383-ae5a-0a2a29cdfbd1