FDA HITS VAPOTHERM WITH WARNING LETTER FOR GMP, QSR DEFICIENCIES
The FDA sent devicemaker Vapotherm a June 12 warning letter for serious good manufacturing practices (GMP) and quality system regulation (QSR) deviations. The FDA posted the letter to its website June 26.
The Stevensville, Md., firm, which makes respiratory gas humidifiers, was inspected by the agency in December 2005 and received a Form 483 on Jan. 5.
The firm issued an urgent nationwide recall of its Vapotherm 2000i devices in January because some of the devices contained the Ralstonia species of bacteria. The firm first learned of the problem from a Pennsylvania hospital on Aug. 17, 2005, and subsequently issued a voluntary recall of the device on Oct. 13, 2005.
The FDA cited the firm for failing to verify and validate corrective and preventive actions (CAPA) to ensure that changes to the firm's processes did not adversely affect the finished device. The firm revised some of its cleaning and disinfection methods but failed to validate them for use with the Vapotherm 2000i, the warning letter says.
The agency also found fault with the firm's complaint-handling procedures. Specifically, the firm used an off-the-shelf software program to collect, track and trend data, but failed to include a procedure explaining how to use the program. Additionally, the firm did not use its complaint-handling standard operating procedures, the FDA said. (http://www.fdanews.com/ddl/33_28/)