Nephron Pharmaceuticals, a drug maker based in West Columbia, is facing ongoing issues with the production of sterile drugs, according to a recent inspection conducted by the U.S. Food and Drug Administration (FDA). The inspection, conducted in February and published this week, revealed several issues related to cleaning procedures, equipment and maintenance problems, inadequate employee training, and improper storage of ingredients.
This latest inspection comes nearly a year after Nephron Pharmaceuticals received a warning letter from the FDA in October 2022, stating that the company had not adequately addressed the issues raised during a previous inspection. As a result of the warning letter, the U.S. Department of Veterans Affairs (VA) initiated an internal recall of all Nephron-made drugs and temporarily halted the ordering and use of the company’s products until conditions improved. In addition, Nephron has already recalled 7.6 million doses of its drugs since May 2022.
In response to the inspection findings, Nephron Pharmaceuticals has made efforts to address the identified issues. The company has hired new talent, engaged expert consultants, and implemented measures to improve its manufacturing processes. CEO Lou Kennedy expressed the company’s commitment to continuous improvement and innovation, stating that they are working hard to ensure patients have access to the life-saving medications they produce.
Nephron has also undergone significant changes in its executive team this year. Key hires include a chief of process engineering, director of quality compliance, and a new president to oversee the company’s 503B Outsourcing arm. These new appointments were made after the FDA’s latest inspection.
The inspection revealed various deficiencies in Nephron’s facilities, including rust on equipment, the use of duct tape on machinery, and improperly sealed sterile rooms. Moreover, employees were observed not following proper sterility practices, such as handling items without sanitizing them and failing to follow inventory tracking procedures accurately.
These issues are consistent with past problems cited by regulators, such as cross-contamination of drugs during the manufacturing process. In one instance, traces of Bupivacaine, a local anesthetic, were found mixed with another batch of drugs produced at the facility.
Nephron Pharmaceuticals has the capacity to produce over 1 billion doses of pharmaceuticals annually and is approved to manufacture 125 types of sterile drugs. The company is determined to address the identified issues and ensure the production of safe and effective medications.
In light of the ongoing concerns surrounding Nephron’s sterile drug production, it remains to be seen how the company will address the FDA’s findings and regain the trust of regulators and consumers.
