Alabama Devicemaker Rapped for Complaint Handling
Ralston Group was slapped with a Form 483 for failing to complete complaint forms and other violations at its Selma, Alabama facility.
During its Feb. 13–Mar. 7 investigation, the agency noted deficiencies with the firm’s complaint handling for its exercise devices, the Feminine Personal Trainer and the Maximum Pelvic Trainer Kegel.
The FDA found that no complaint forms were completed for 31 complaints seen on a complaint log for the exercise devices.