Cardinal Health 418, Inc. – FDA 483, Jun 18, 2026
An FDA inspection of Cardinal Health 418, Inc. in Aurora, CO, a drug manufacturer and contract laboratory, revealed significant deficiencies across its quality system, facilities, and equipment. The firm was cited for inadequate investigation records, failure to follow quality control procedures, insufficient equipment maintenance, and lack of proper cleaning procedures for manufacturing equipment. These issues indicate a moderate level of severity regarding compliance with good manufacturing practices.
ID · d1746384-203b-414d-a3e5-3ac97f052410
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