In Vivo Metrics Systems, a manufacturer of cutaneous electrodes, received a warning letter from the FDA about devices the agency deems "adulterated" due to nonconformance with good manufacturing practices (GMPs).
The agency conducted its inspection Sept. 13-30 in 2005, at the firm's location in Healdsburg, Calif.
Among the "significant deviations" the FDA identified in its warning letter were failures by In Vivo to "define, document and implement procedures for quality audits," and to ensure those audits were in line with quality system (QS) requirements and that the quality system was effective. The company was cited specifically for limiting its quality audit procedures to manufacturing equipment inspections rather than including "other quality subsystems such as design controls, production and process controls, management controls, and corrective and preventive actions."
The company did not adequately document corrective actions or verify whether they were effective, the agency noted. In Vivo also did not validate "with a high degree of assurance" the sterilization process recommended in the labeling of its cutaneous electrodes, the FDA said.
Additionally, the FDA said the firm's master records for particular devices did not refer to or include the location of device specifications; and that the device history records failed to "include the dates of manufacture, quantity manufactured, quantity released for distribution, acceptance records and labeling for the device."
The firm was also cited for not adequately documenting acceptance activities for visual and continuity tests performed on devices, the dates and results of those activities, and the signature of the person overseeing them.
The FDA further faulted the company for not establishing and maintaining complaint procedures, and in particular for failing to determine when a complaint was serious enough to be filed as a medical device report.
In Vivo also did not implement procedures to ensure that all products and services received by the company conformed to specified requirements. In particular, there was not appropriate control of purchases of lead wire and silver-silver chloride compounds, the FDA said. ()a href="http://www.fdanews.com/ddl/33_14/" target=_blank>