Surgical Instrument Maker Racks Up 11-item 483
Lax medical device reporting and CAPA procedures as well as a host of other quality issues were uncovered during a July 31 to Aug. 2 FDA inspection of LED Intellectual Properties’ Irvine, Calif. facility.
Corrective and preventive action SOPs were found lacking because procedures didn’t define requirements for dealing with existing or potential quality problems, the 11-item 483 said. The FDA inspector noted that the firm’s CAPA procedures didn’t require investigation to identify underlying causes for potential problems and a requirement to convey information to a responsible person.
The firm had no documentation for CAPA activities and complaints weren’t handled in a timely manner. For example, at least five complaints were received but they were not fully investigated for at least six months.
LED’s supplier controls were found to be lacking in that products were rejected for damage and flaws, but there were no CAPA investigations to determine the underlying cause of the nonconformances.
In addition, the inspector noted repeat observations related to inadequate device history records from a previous May 2016 inspection.
Read the LED Intellectual Properties Form 483 here: www.fdanews.com/12-13-18-ledintellectualpropertiesllc483.pdf.
Managing the Complaint Management System Maintaining an effective complaint handling system requires attention to detail, robust internal audits and a solid training program. There are a few steps that companies can take to ensure the regulatory success of their complaint handling systems. One is simply to check the procedures. A complaint handling system that meets all QSR requirements must include a large number of procedures, so a check to confirm that all of these are under document control, as laid out in 21 CFR 820.40 – Document Controls, can help catch any details that may have fallen by the wayside. Likewise, a requirement-by-requirement review of each procedure against the pertinent regulations can help to ensure that the complaint handling and MDR procedures are fully compliant. For every sentence in the regulations, you should have a place where it’s addressed in your procedure. “If you have multiple procedures and work instructions, which often happens, make sure you review them together to make sure that everything is covered and that there are no inconsistencies,” says quality expert Dan O’Leary, president of Ombu Enterprises. Keeping up with training also can be a challenge. It’s essential that everyone involved in the complaint handling process understands how those processes work and who is responsible for what. All employees who could potentially be involved in complaint handling must be trained in complaint procedures, and all training must be documented and training records maintained. Sharing Data Complaint data is an important resource for your CAPA department, so your complaint system should feed data into your CAPA system. Not all complaints will result in corrective action, but you should set clear criteria in your system to determine which complaints go on to that stage and how they will be handled. Your complaint system also can feed data to the corporate management level to keep them informed. Managers are particularly interested in data on open complaints: how many; how long they have been open; what is their status. And for multisite corporations, managers can use complaint data to track problems by product line and facility. Linking complaint data to other internal data sources in such areas as incoming acceptance, nonconforming materials, installation and servicing can help give management a broader view of corporate operations. Ultimately, you can use your complaint data to evaluate the effectiveness of the complaint management system itself. Excerpted from the FDAnews management report: Complaint Management for Devicemakers —From Receiving and Investigating to Analyzing Trends. |