Nephron drug production process called ‘inadequate,’ ‘non-compliant’ by Canadian probe
A recent inspection at a South Carolina drug production facility flagged several problems with how the company was producing drugs for the mass market, little more than a year after the same facility faced such scrutiny from U.S. regulators that it recalled products and lost the confidence of a major federal agency.
Inspectors from the Canadian health agency Health Canada visited the Lexington County manufacturing center of Nephron Pharmaceuticals for several days in October and gave the facility an overall “non-compliant” rating. The inspectors highlighted several deficiencies it found in how Nephron makes its health products.
The report, available on Health Canada’s website, called into question the sterility of the company’s production process, something Nephron has been called to task for in the past. The Canadian agency said Nephron’s “cleaning of the premises and the equipment in aseptic areas was inadequate,” “The company did not take precautions to minimize contamination during all processing prior to sterilization,” and “The validation of equipment or the planned maintenance of equipment was inadequate.”
Health Canada also noted, “The implementation, effectiveness, and/or validation of the cleaning procedures was inadequate for preventing unsanitary conditions” and that “The education, experience, and/or oversight of the individual in charge of the manufacturing department was inadequate.”
The Canadian health agency inspected Nephron’s facilities as part of its regulation of pharmaceuticals available in Canada, ensuring the American-made drugs and products are compatible with Canadian law.
In declaring Nephron “non-compliant,” the Canadian regulators concluded “the company was not conducting the regulated activity ... in compliance with the (Canadian) Food and Drugs Act or its Regulations.”
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Nephron makes inhalation products and pre-filled medications at its Lexington County facility. At one point, it was one of the few manufacturers in the United States to manufacture the asthma and COPD medication albuterol, and in recent years the company has expanded its offerings to include a plant for making medical gloves, a syringe manufacturer and, in response to the COVID-19 pandemic, the rapid production of new test kits.
“Nephron continues to work collaboratively with the FDA — and any other agency — to resolve any questions regulators have about company processes — part of the company commitment to the highest standard of quality for patients everywhere,” Nephron said in a statement to The State. “The work we do makes us stronger every day.”
This isn’t the first time regulators have criticized practices at the facility on 12th Street Extension south of Cayce, which opened in 2015 and at one point employed more than 4,000 people.
In 2022, Nephron recalled more than 2 million items across several production lines, following an inspection by the U.S. Food and Drug Administration that raised similar concerns about whether sterilization had been compromised at various points during the production process.
By the end of that year, the U.S. Department of Veterans Affairs warned veterans’ facilities not to use Nephron products, affecting almost 40,000 veterans who had been using the products. In February 2023, the company announced it had furloughed an unspecified number of employees for three months in response to a “business need,” sparking concern about the health of the company, although Nephron never formally notified the S.C. Department of Employment and Workforce of any layoffs, as is required by state law.
