FDA Still Investigating Nephron Pharmaceuticals

Getting your Trinity Audio player ready...

by WILL FOLKS

***

Investigators with the U.S. Food and Drug Administration (FDA) returned to the West Columbia, South Carolina campus of crony capitalist drug manufacturer Nephron Pharmaceuticals this month, multiple sources familiar with the situation have confirmed.

According to our sources, FDA investigators arrived at Nephron two weeks ago (August 11, 2025) and have been on the campus for the past two weeks. Company loyalists say the agency is “nitpicking since they cannot find any major violations,” however other insiders indicated the feds have been “combing through” a wide range of core products – including breathing treatments as well as “a lot of 503B product.”

“503B” is the FDA’s designation for facilities permitted to “manufacture large batches (of pharmaceuticals) with or without prescriptions to be sold to healthcare facilities for office use only.” Facilities which manufacture such batches must follow the FDA’s Current Good Manufacturing Practice (CGMP) regulations in order to “assure proper design, monitoring, and control of manufacturing processes and facilities.”

“This includes establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories,” the regulations note. “This formal system of controls at a pharmaceutical company, if adequately put into practice, helps to prevent instances of contamination, mix-ups, deviations, failures, and errors. This assures that drug products meet their quality standards.”

***

Adhering to such scrutiny has been an issue for Nephron in recent years. FITSNews has reported extensively – and exclusively – on Nephron’s chronic issues, including mass layoffs of employees, recalls of product and multiple FDA inquiries. Most recently, we reported five months ago on bizarre social media posts made by Nola Grant, Nephron’s former chief human resources officer. In April, Grant posted to her LinkedIn page asking fellow human resource professionals to offer their thoughts on a “CEO directed ‘cover up’ in the guise of night with the clearing out, hauling off via truck loads and the destroying of equipment, documents and items from a warehouse.”

The purpose of the alleged cover-up?

“All to avoid FDA knowledge, visibility and accessibility… (and) to intentionally help LIE to the FDA about the use of that facility and the items stored there,” Grant added.

Grant isn’t the only Nephron employee to raise these issues. Just this week, a current employee referenced batch records of drug manufacturing runs from the company which were “an absolute disaster.”

“They were missing half (of) the documentation and the documentation that was there was incorrect and had been ‘incorrectly corrected’ multiple times,” the employee noted.

According to this employee, a quality supervisor at Nephron “was trying to hide (the records) when the FDA showed up.”

Why are these records so important?

***

RELATED | CRONY CAPITALIST FAIL

***

“The batch record is the birth certificate of every batch of whatever they make,” another insider told us. “If the batch record is incomplete or incorrect it could result in a recall and or a fine. They always had trouble with batch records.”

Grant’s ostensibly hypothetical post in April referenced multiple employees resigning from the company in question due to “the CEO’s hostile behavior, threats, unprofessional commentary and failure to adhere to regulatory best practices, which created a continuous debacle of fires and unnecessary cleanup.”

She also claimed federal, investor and regulatory audits of recent projects having been “spiked.”

Nephron’s issues with federal agencies are voluminous. In early 2023, the U.S. Department of Veterans Affairs (VA) announced a recall of “all medicines made by Nephron Pharmaceuticals” due to a “fear of contaminated drugs.” In September of 2020, the company was accused of running afoul of the Federal Trade Commission (FTC) after falsely advertising that its products were made in America.

Nephron claimed its drugs were “proudly made in the USA,” but chief executive officer Lou Kennedy has privately acknowledged “most all of my active pharmaceutical ingredients from Europe and other countries.”

Despite its ongoing troubles, Nephron has been a darling of South Carolina crony capitalists like former governor Nikki Haley, current governor Henry McMaster, lieutenant governor Pamela Evette and commerce secretary Harry Lightsey. The company has received tens of millions of dollars in taxpayer-funded subsidies from Palmetto politicians over the past decade-and-a-half – even as it has failed to meet promised employment goals.

Count on FITSNews to keep our audience in the loop on the latest developments related to this ongoing investigation…

***

ABOUT THE AUTHOR…

Will Folks is the founding editor of the news outlet you are currently reading. Prior to founding FITSNews, he served as press secretary to the governor of South Carolina. He lives in the Midlands region of the state with his wife and eight children.

***

WANNA SOUND OFF?

Got something you’d like to say in response to one of our articles? Or an issue you’d like to address proactively? We have an open microphone policy! Submit your letter to the editor (or guest column) via email HERE. Got a tip for a story? CLICK HERE. Got a technical question or a glitch to report? CLICK HERE.