483
Gram Laboratories IncFDA 483 - Gram Laboratories Inc - September 04, 2015
Record Details
Gram Laboratories, Inc., a contracted control testing laboratory in Irvine, CA, was cited for significant deficiencies in its quality control unit, laboratory computer system controls, and investigation procedures. The inspection revealed issues with data integrity, unvalidated spreadsheets, inadequate calibration procedures, and insufficient employee training, indicating a lack of robust quality management.
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ID · 5581dd6f-53f4-440e-9826-fe1af414521b