A recent FDA inspection at Utopia Group, a specification developer for Loveland, OH-based Joey Medical’s Joey Spray Guard umbilical cord clamp and cutter, found multiple Quality System Regulation violations, according to a May 21 Warning Letter from the agency’s Cincinnati District Office.
Specific violations noted on a FDA-483 included:
- Failing to establish and maintain procedures to ensure that all purchased or otherwise received products and services conform to specified requirements.
- Failing to establish and maintain procedures to control the device design to ensure that specified design requirements are met and demonstrate that the design was developed in accordance with the design control requirements.
- Failing to establish and maintain procedures for implementing corrective and preventive actions, and to document all activities required under that regulation.
- Failing to establish and maintain procedures to control product that does not conform to specified requirements.
- Failing to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit.
- Failing to establish and maintain procedures to control all documents required by regulations.
- Failing to establish procedures for quality audits and to conduct such audits to assure that the quality system complies with the established quality system requirements and to determine quality system effectiveness.
- Failing to establish procedures for identifying training needs and ensuring that all personnel are trained to adequately perform their assigned responsibilities.
- Failing to have management with executive responsibility ensure that an effective quality system has been established and implemented.
The adequacy of the firm’s response to the observations could not be determined at this time, the letter says. The inspection also found that the company failed to develop written medical device reporting procedures.
Utopia was told to take prompt action to correct the violations and to respond with a list of steps taken, documentation of each step, and a timetable for completion.
—Jim Dickinson is MD+DI's contributing editor.
[image courtesy of KIBSRI/FREEDIGITALPHOTOS.NET]