ARJ Warned for Not Having Several Written Procedures

September 24, 2010
ARJ Medical has received a warning letter citing it for lack of written procedures for its urinalysis reagent strips.

An FDA investigator noted that a company official told him during a March inspection that ARJ had no written medical device reporting procedure, as well as a number of other written procedures.

In addition, ARJ had not developed a quality policy. The company’s responses to the observations in the Form 483 are inadequate because they do not fully address the requirements, the FDA says.
The GMP Letter