The FDA handed Ultroid Technologies a Form 483 after an inspection revealed inadequate corrective and preventive action (CAPA) procedures.
The August inspection noted ten observations, including that Ultroid’s CAPA records did not identify why seals were broken in a kit used with a hemorrhoid management system. CAPA records also did not clearly show that user errors caused problems with the system’s cable connections.
In addition, Ultroid’s records did not cover review, verification, or validation of a change to a sterile barrier for the probe used with the Hemorrhoid Management System. There also were no records covering verification or validation of a change to the cable for the system’s hand piece.
Ultroid also did not fully implement its internal quality audit procedures or make available for copying the production and labeling records for its Hemorrhoid Management System.
The full form can be seen here: www.fdanews.com/12-09-16-UltroidTechnologies.pdf. — Derek Major