The FDA has OK'd a plan by H&P Industries/Triad Group for the disposition of $6 million in products, mostly sterile wipes and alcohol swabs, impounded by U.S. marshals in April. The plan approval is an early step in the consent decree journey of the corporate kin and three named individuals, presumably brothers David and Eric Haertle and their sister, Donna Petroff.
H&P will recondition those products that can be made safe and will destroy the others, according to MSNBC. No other details of the remediation plan were available prior to publication.
MSNBC says also that the company's manufacturing plant in Hartland, WI, is now up for sale.
The H&P/Triad operation was shut down in June, two months after a raid by U.S. marshals who seized the $6 million in products. Last January, the company conducted a major recall of alcohol prep products contaminated with Bacillus cereus, which were later believed tied to more than 10 deaths. In late February, FDA investigators tallied an unusually high 46 observations on a Form 483 report after a plant inspection.
As with all FDA/manufacturer consent decrees--and in sharp contrast with the process unfolding between the FDA and Rockline Industries over the latter's bacteria-tainted but less strictly regulated baby wipes--H&P is required to retain a GMP consultancy for the remediation effort. In addition, the company hired Eamonn Vize as COO, replacing Eric Haertle. Vize, an Abbott Labs operations and validation vet, was recruited to lead "task force projects and FDA pre‐approval inspection teams," according to a company statement.
It's a steep uphill climb, one that the company estimates will take 5 years, says MSNBC. Manufacturing will remain shut down until the FDA deems its QA/QC practices in compliance with Good Manufacturing Practices.
- here's the story
- see this earlier MSNBC report
- here's the June consent decree announcement
- see the Vize announcement