The other shoe has dropped. H&P Industries, whose plant in Hartland, WI, was idled recently following a product seizure, is now operating under a consent decree with the FDA.
The decree allows H&P, whose products are distributed by Triad, to continue working on the comprehensive action plan it filed in January to improve quality systems, according to a company statement. The plan "identifies procedures that will help provide additional assurance of product quality to the FDA."
President Eric Haertle, who recently relinquished his COO role at H&P, says his company is "fully committed" to addressing the agency's concerns. He also hired an independent expert to inspect the facility, make recommendations and direct H&P on a work plan. The FDA's approval of the work plan will green-light H&P to resume manufacturing.
The company anticipates at least five years of consent decree operations.
H&P was the late-February recipient of a 46-count FDA Form 483 inspection report and was shut down by the agency in April after U.S. Marshals seized $6 million in products and inventory. The actions followed three recalls of sterile and non-sterile alcohol wipes and swabs possibly contaminated with bacteria.
- see the H&P/Triad announcement