The heat is rising for Triad, maker of the recently recalled alcohol prep pads, wipes and other products. Suspicions are growing that the products, allegedly contaminated with the dangerous bacteria Bacillus cereus, may be responsible for the death of a two-year-old and the open-heart surgery of a 55-year-old former iron worker. Complaints and reports relating to the products began mushrooming when the first recall was announced Jan. 5.
As the story gets a vetting in the daily press, the FDA is beginning to feel the heat, too. Records of FDA inspections of Triad's Wisconsin plant from 2009, 2010 and even Jan. 7--following the recall--show repeated instances of GMP noncompliance.
The regulator last week posted the sizable Form 483 inspection report from that most recent visit and several others. It contains 46 observations.
The quotes being pulled from the report and used in press accounts are far from pretty: non-gloved employees packing acne pads into containers; microbial contamination in the water pipes used in making mouthwash and suppositories; and workers lying when confronted about omitting the active ingredient in children's cold medicine.
These home-hitting transgressions from the inspection report appear alongside the more mundane: unverified and unvalidated sterilization processes; lack of contamination control processes; lack of procedures for testing conformance of raw materials with specs; and product release after QA failure on the say-so of the company president. He later reversed his decision, reports MSNBC, but some product had been shipped by then.
FDA statements appear to be fueling the fire. MedPage Today quotes Mike Rogers of the Office of Regulatory Affairs as saying the agency determined that the problems, despite being repeat violations, indicated only a need for voluntary action. So it issued no warning letter, deciding the more effective course was to "work with the firm" as it made the corrections.
Rogers says the agency is "very concerned" about the repeat violations from the post-recall inspection.