Nephron SC Inc.

Warning LetterOpen

Ms. Lou W. Kennedy Chief Executive Officer and Owner Nephron SC Inc. 4500 12th Street Ext. West Columbia , SC 29172 United States lkennedy@nephronpharm.comFEI 3010892830Issued Oct 11, 2022Office of Pharmaceutical Quality Operations, Division II

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3010892830.

Violations6

Issue DateOct 11, 2022

Product TypeDrugs

StatusOpen

Letter Details

Firm: Nephron SC Inc.
Location: Ms. Lou W. Kennedy Chief Executive Officer and Owner Nephron SC Inc. 4500 12th Street Ext. West Columbia , SC 29172 United States lkennedy@nephronpharm.com
FEI Number: 3010892830
Country: United States
Issue Date: October 11, 2022
Issuing Office: Office of Pharmaceutical Quality Operations, Division II
Product Type: Drugs
Status: Open

Summary

Nephron SC Inc., a pharmaceutical manufacturer, failed to comply with Current Good Manufacturing Practice (CGMP) regulations for finished drug products, rendering their drugs adulterated. During a March-April 2022 inspection, the FDA identified critical violations including failure to thoroughly investigate unexplained discrepancies or specification failures in batches of sterile injectable products (Sterile Water for Injection, Ketorolac Tromethamine Injection, and Sodium Chloride Injection), inadequate investigations for both terminal sterilization and aseptic processing products, and failure to submit a required NDA Field Alert Report to the FDA within three working days of discovering significant changes or deterioration in distributed drug products.

Nephron SC Inc. FDA Warning Letter, October 11, 2022