INFRASONICS RECURRENT GMP PROBLEMS ARE SUBJECT OF MEETING WITH FDA

INFRASONICS RECURRENT GMP PROBLEMS ARE SUBJECT OF MEETING WITH FDA scheduled for March 12. In a Feb. 23 letter to the firm, FDA told the ventilator manufacturer that it wanted "to discuss the necessary measures implemented to ensure compliance with the good manufacturing practice regulations." The agency noted that "many of the deficiencies noted during our recent inspection have been brought to your company's attention in past inspections." The agency also said that it is "imperative" that the firm and the agency meet "in light of the recent recall initiated by [the] company involving the Adult Star Series Infrasonics Microprocessor Ventilator for premature termination of respiratory function due to...incompatibility between software and the flow control values." A group of Adult Star ventilators was recalled Dec. 11 because at some settings, the devices' software may malfunction, resulting in insufficient ventilation under certain circumstances ("The Gray Sheet" Feb. 22, p. 12). The firm says it recently completed the recall, which involved a software correction to 430 units in the field. In the warning letter, FDA maintains that Infrasonics' Feb. 4 response to the agency's FD-483 from a Jan. 6-26 inspection did not adequately address four GMP violations. Among the outstanding problems, FDA maintains, is the firm's failure "to assure that all production and quality assurance measurement equipment [is] routinely calibrated." For example, "there is no record documenting the calibration of the...EPROM programmer," the letter said. EPROM programming problems, the agency noted, also caused failures of the Infant Star neonatal ventilator that resulted in another FDA inspection in May 1987. Another remaining agency "concern" noted in the letter is that Infrasonics has not assured that cleaning and manufacturing materials are removed from their products or "limited to a specified amount that does not adversely affect the device's fitness for use." For example, "there are no specifications or acceptance criteria for compressed air used to perform leak tests on bacterial filters," FDA stated. Noting that macroscopic foreign matter found in sterile or non-sterile devices constitutes filth under the Food, Drug and Cosmetic Act, the letter asked that Infrasonics describe its program to assure that finished devices are not contaminated. The two additional violations that were not addressed in the company's response, according to FDA, are the failure to maintain "written results of complaint and failure investigations" and establish an "adequate complaint handling program." FDA said that its inspection showed that "results of investigations or reason(s) why no investigation was performed are not always documented." It adds that "an adequate complaint handling program provides feedback from users to manufacturers about the effectiveness of the manufacturing and quality assurance program and the safety and effectiveness of a device." Infrasonics says it still is formulating its response to the warning letter. The company says it intends to fully comply with FDA's GMP concerns before it issues a response.