Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center, LLC

Warning LetterOpen

Lou Wood Kennedy CEO and Owner Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center, LLC 4500 12th Street Extension West Columbia , SC 29172-3025 United StatesFEI 3010247115Issued Oct 21, 2022Office of Pharmaceutical Quality Operations, Division II

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Violations6

Issue DateOct 21, 2022

Product TypeDrugs

StatusOpen

Letter Details

Firm: Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center, LLC
Location: Lou Wood Kennedy CEO and Owner Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center, LLC 4500 12th Street Extension West Columbia , SC 29172-3025 United States
FEI Number: 3010247115
Country: United States
Issue Date: October 21, 2022
Issuing Office: Office of Pharmaceutical Quality Operations, Division II
Product Type: Drugs
Status: Open

Summary

Nephron Pharmaceuticals Corporation, an outsourcing facility registered to compound sterile drugs, produced adulterated drug products that failed to meet the conditions required under section 503B of the Federal Food, Drug, and Cosmetic Act for exemptions from drug approval requirements. FDA investigators found serious deficiencies in the company's sterile compounding practices during a March-April 2022 inspection that put patients at risk, including a lack of sterility assurance in certain products. The company initiated voluntary recalls of sterile drug products within expiry in May and June 2022 in response to these deficiencies.

Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center, LLC FDA Warning Letter, October 21, 2022