Breast Pump Maker Fails to Establish Adverse Event, MDR Procedures

Class II breast pump manufacturer A Cute Baby failed to establish written medical device reporting procedures as well as procedures for evaluating complaints, according to a Form 483 the firm received following a Dec. 7, 2017 inspection of the firm’s Orem, Utah facility.

The FDA inspector said that the firm didn’t have any approved procedures in place for handling adverse events or for evaluating complaints.

The 483 also highlighted deficiencies in training and identifying training needs.

The firm lacked procedures for training employees in MDRs, complaint handling, and servicing for the devices. In addition, employees do not have documented training records for these activities.