> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Still Finding Issues at Nephron Pharmaceuticals
- URL: https://www.fdaweb.com/fda-still-finding-issues-at-nephron-pharmaceuticals/
- Published: 2025-10-22T12:00:00.000Z
- Updated: 2026-09-14T15:24:44.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160088

After receiving several Warning Letters from FDA. Nephron Pharmaceuticals in Columbia, SC, still does not have the needed systems in place to ensure its products are made in a sterile environment. In a news story posted on Yahoo! News, *The State*, a newspaper in Columbia, [says](https://www.yahoo.com/news/articles/recent-fda-inspection-reveals-nephron-090000749.html?ref=fdaweb.com) Nephron’s most recent inspection report indicated that some issues, like a lack of proper investigation into reported issues with the company’s drugs and insufficient procedures for monitoring how products are made, have plagued the company for years.

The article says the 8/11-8/22 inspection came three years after the company received two Warning Letters citing several quality issues. The newspaper quoted these findings from what appears to be a form FDA-483 issued following the inspection:

- failure to establish written procedures designed to prevent microbiological contamination of drug products purporting to be sterile;
- aseptic processing areas are deficient regarding the system for monitoring environmental conditions;
- failure to thoroughly review the failure of a batch or any of its components to meet any of its specifications, whether or not the batch was already distributed;
- failure to establish adequate written procedures for production and process controls designed to assure that drug products have the identity, strength, purity, and quality they are purported or represented to possess;
- aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure; and
- failure to fully follow the responsibilities and procedures applicable to the quality control unit.

The newspaper says FDA has not issued close-out letters for the 2022 Warning Letters, signaling that, according to an agency spokesperson, “compliance activities for this firm are ongoing.”

Company officials declined to comment to *The State*. The article quotes academic experts as indicating FDA has the legal authority to close the company or go beyond Warning Letters to issue a cease and desist order if conditions warrant such action.