J&J Confide home HIV test kit fails GMPs for filter blood absorbency -- FDA warning letter.
This article was originally published in The Tan Sheet
Executive Summary
J&J CONFIDE HIV HOME TEST KIT FAILS BLOOD ABSORBENCY TEST GMPs, FDA states in a warning letter sent to Johnson & Johnson's Direct Access Diagnostics company on May 28. FDA considers the home test kit adulterated in that it does not to conform to Good Manufacturing Practices for medical devices as pertains to the validation of blood tests; Confide also is considered misbranded because DAD did not submit information on the product required by the medical device reporting regs, FDA says; and the company is not collecting the required demographic information from Confide test kit users as mandated by the premarket approval application dated May 14, 1996. The warning letter was issued following postmarketing inspections of the company's manufacturing facility in Bridgewater, N.J. from March 24 through April 4.