Quality control inspector Kathleen Smith says she regrets not reporting unsanitary conditions at H&P's Hartland, WI, manufacturing plant to authorities in 2010. The plant was shut down last week following an FDA-ordered raid by U.S. Marshals (see related story).
Smith said she was fired last May for unsatisfactory performance. But she contends that her complaints to supervisors about improper equipment cleaning and employees "sneaking" items into areas used for production of sterile products led to her dismissal. She told the Milwaukee Journal Sentinel that production equipment was not always sanitized, and that "people were threatened with being fired if they reported it."
H&P cofounder Eric Haertle "strongly denies" the allegations. "If I was aware of those [practices], they certainly would not have continued. I do not believe they occurred," he says in the story.
Additional allegations by Smith: Pills belonging to an employee were accidentally packed into a box of iodine wipes, which was returned unused by a retailer. And an employee cut her finger while packing alcohol-wipe packets and the product was shipped with blood inside and outside the box. Other former employees said a Spanish/English language barrier hindered quality efforts. According to the story, Smith said she was told to falsify training test results for employees who could not read English.
- here's the story