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DAD Confide home HIV test kit fails GMPs for filter blood absorbency -- FDA warning letter.

This article was originally published in The Gray Sheet

Executive Summary

J&J CONFIDE HIV TEST KIT FAILS BLOOD ABSORBENCY TEST GMPs, FDA states in a warning letter delivered to Johnson & Johnson company Direct Access Diagnostics on May 28. FDA considers the home test kit adulterated in that it does not conform with the good manufacturing practice regs for medical devices as it 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 reg, FDA says. In addition, the company is cited for 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 an inspection of the company's facility in Bridgewater, New Jersey March 24 through April 4.
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