Company: WNCK Inc.Product: BreathScan Detector Date: 9/30/04 Failure to establish and maintain procedures for implementing corrective and preventive action [21 CFR 820.100(a)] [FDA-483 Item 7]. For example, your firm maintained electronic communication records with distributors or customers, but there were no records showing your firm’s evaluation of or action taken on quality issues. FDA District:...Read More