FDA Flags J&J For Inadequate Oversight Of Consumer Devices

摘要

Two years into its OTC drug quality-control remediation program, Johnson & Johnson has received an FDA warning letter concerning the firm's handling of consumer complaints for consumer products regulated as devices. The May 22 letter cites violations related to K-Y brand moisturizers, O.B. tampons and Reach dental floss and suggests that J&J, the world's largest medical-device company, has not devoted the same level of resources and organizational oversight to consumer devices that the firm says it has for OTC manufacturing.