Today Invacare Corporation (NYSE: IVC) commented on an FDA warning letter related to an inspection of the Company's bed manufacturing facility in Sanford, Florida. The warning letter takes issue with Invacare's compliance with the FDA's Quality System Regulation, specifically related to Invacare's ability to establish and maintain adequate procedures to analyze processes and operations and to document actions taken on product complaints.
"Invacare wants to assure users and the general public that we rigorously test our products and stand fully behind the safety of our products. The FDA warning letter does not state that our products are unsafe nor has it impacted our production. The letter is related to documentation procedures. We take all FDA matters very seriously, and we intend to address all of the FDA's concerns," said Gerald B. Blouch, president and chief executive officer.
The Company has assembled a team including its internal quality and regulatory associates as well as outside experts to address the agency's concerns. A formal response including short term and long term actions will be submitted to the FDA as is required under the letter.