FDA Inspector: Device Firms Have Problems with CAPA, Complaint Handling

Originally Published MDDI January 2004

NEWSTRENDS

Erik Swain

Corrective and preventive action (CAPA) and complaint handling are among the most common sources of deficiencies cited in FDA inspections of device companies, an agency official said. Lori S. Lawless, an investigator in FDA's Baltimore District, offered attendees at the Regulatory Affairs Professional Society (RAPS; Rockville, MD) annual conference a list of the most common violations she sees, and some tips on how to prevent them. The conference was held in October 2003 in Baltimore. 

“Most violations come down to one of three things,” she said. “Do your procedures follow the regulations? Do you follow those procedures? And do you document that you follow them?”

She said the top 10 most common violations involve:

• Procedures for implementing CAPA. “The device regulations go back to the procedures not being established, and if something is not implemented, that means it's not established. Often we will find there are written procedures but no true root-cause analysis, and we will find that failure investigations are inadequate.” Citing “employee error” is a big issue, said Lawless. “They do what they're told. It always comes down to management. They should have caught it.”
• Complaint handling. “A lot of it is too specific and does not look at the overall system,” she said. “You might have addressed a problem in one lot, but a complaint also can mean it's in other lots.”
• Inadequate MDR reports.
• Failure to document CAPA action.
• Validation. “You have to look at all your systems as if you've never seen them before,” Lawless said. “That's difficult to do. It is always good to get people not familiar with your systems to find things.”
• Frequency of quality audits. “If I'm finding a lot of stuff, it probably means you're not auditing enough,” she said.
• Failure to designate executive responsibilities. “These need to be documented,” she said. “This is another case of ‘if it's not documented, it's not been done.'”
• Inadequate procedures for quality audits. “We need to know what you are looking for, what happens when it is done, and what you will do with the information,” she said. 
• Inadequate procedures for design changes. “Everything needs to be evaluated. Safety and hazard analyses need to be performed, or you need to document why you don't need them,” she said. “You also need to show whether it needs to be validated again.”
• Inadequate procedures for documenting CAPA. 

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