FDA warns Invacare about its complaint process

WASHINGTON – The U.S. Food and Drug Administration on Nov. 18 sent Invacare a warning letter outlining a number of violations found during an inspection earlier this year. 

The violations include, but are not limited to, the following: 

• Failure to investigate any complaint involving the possible failure of a device, labeling or packaging to meet any of its specifications, unless such investigation has already been performed for a similar complaint and another investigation is not necessary. 
• Failure to establish and maintain adequate procedures for receiving, reviewing and evaluating complaints by a formally designated unit. 
• Failure to establish and maintain adequate procedures for implementing corrective and preventive action that shall include requirements for using appropriate statistical methodology where necessary to detect recurring quality problems. 
• Failure to establish and maintain procedures for implementing corrective and preventive actions. 
• Failure to submit a report to FDA no later than 30 calendar days after the day that your firm received or otherwise became aware of information, from any source, that reasonably suggests that a device that your firm markets has malfunctioned and this device or a similar device that it markets would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur. 

“Your firm should take prompt action to correct the violations addressed in this letter,” the FDA states. “Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice.” 

The FDA asked Invacare to notify the agency in writing within 15 business days from the date they received the letter of the specific steps they have taken to correct the noted violations, as well as an explanation of how they plan to prevent these violations for occurring again.  

Invacare says it plans to address all of the FDA's concerns in a timely manner.

"Invacare wants to assure our customers that we stand behind the quality and efficacy of our products," said Matt Monaghan, chairman, president and CEO in statement to HME News. "The FDA letter guides us to expanded processing of post-market complaints and related procedures. We take these matters seriously and will continue our substantial efforts to improve the robustness of our processes and procedures.”