Help Wanted: Chief operating officer to manage remediation of manufacturing at shut-down OTC-products plant in Wisconsin. Extensive pharmaceutical ops experience required. Must be able to work effectively with consultants and no-funny-business regulators. Strong interpersonal skills a must. Write to: H&P Industries, att: Eric Haertle, co-owner and COO.
That might well be the essence of what Haertle is looking for as he relinquishes the COO part of his job at Triad/H&P Industries, the manufacturer of recalled wipes that was shut down last week after U.S. Marshals seized $6 million in products and inventory on behalf of the FDA. The seizure follows three recent recalls of sterile and non-sterile alcohol wipes and swabs possibly contaminated with bacteria.
H&P was also recently stung by a 46-count FDA Form 483 inspection report, which is now being compounded by a story in Wednesday's Milwaukee Journal Sentinel detailing GMP-violation and QC-failure allegations made by former employees.
Haertle has already hired the consultants, former FDA regulators among them, the newspaper says. He denies the allegations of the former employees quoted in the story, citing the company's 30 years of manufacturing as evidence that it "takes quality seriously."
- here's the story