Craftmatic Warned for Complaints About Therapeutic Beds
The FDA has warned Craftmatic Industries over inadequate complaint handling and manufacturing procedures for its Adjustable Home-Use Therapeutic Bed.
The Feb. 17 letter, posted recently online, says the Miami Beach, Fla., company’s complaint investigation records don’t include required data about the nature of the complaint, the date it was received, the complainant’s contact information, the dates and results of the investigation and corrective actions taken.
The letter cites several events described in customer insurance claims that were investigated by Craftmatic, including property damage from fire in 2009, 2010 and 2011, and separation of a bed base in 2013.
The company has a complaint handling and failure investigation procedure, but it doesn’t include a retrospective review of all investigations, including those listed in the letter, to ensure proper handling and documentation.
Craftmatic also doesn’t maintain records of acceptable suppliers, and the company’s purchasing control procedures fail to select potential suppliers, contractors and consultants on the basis of their ability to provide quality products and services.
The FDA also dings the devicemaker’s design control procedures. According to the warning letter, the company doesn’t define, document and implement procedures to control the design process, including requirements for design reviews, verification, validations and changes.
A design review procedure provided to the investigator appeared to be in draft form because it had no signature or approval date.
Other lapses identified by the investigator include failure to maintain CAPA files and procedures, and lack of procedures for quality audits.
The letter, which followed a June 25 through Aug. 8, 2014, inspection also cites the company’s failure to maintain device master records for the therapeutic bed.
Craftmatic Vice President Eric Kraftsow tells GMP the firm takes compliance with FDA regulations seriously and has responded to the warning letter.
Read the warning letter at www.fdanews.com/03-19-2015-Craftmatic.pdf. — Charlotte Astor