ARJ Warned for Not Having Several Written Procedures

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, according to the July 16 warning letter posted last month. The Oldsmar, Fla., company also had no written procedures for corrective and preventive action, complaint handling, specification conformance of purchased products and services, and design control, including labeling requirements.
The GMP Letter