Galbraith Laboratories Inc – FDA 483, Jun 16, 2026
Advanced Testing Laboratory Inc, a contract testing laboratory in Knoxville, TN, was cited for significant deficiencies in its quality system. The inspection revealed a failure to thoroughly investigate discrepancies and ensure corrective and preventive actions effectively address root causes of recurring problems, particularly concerning expired standards and reagents. Additionally, the firm's quality control unit demonstrated inadequate oversight of the CAPA system, with numerous past-due CAPAs lacking documented resolution or management action.
ID · d9066aa3-0fa8-4d06-88cf-708342f54923
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