Nephron SC Inc.
FDA issued a warning letter to Nephron SC Inc. (West Columbia, SC) following a March–April 2022 inspection that found significant CGMP violations at its drug manufacturing facility. The agency cited failures to adequately investigate cross-contamination of drug products (including Bupivacaine detected in other drug lots), inadequate response to microbial contamination (Pseudomonas aeruginosa) in aseptic processing, deficient environmental monitoring in ISO 5 critical areas, and a failure to submit required NDA Field Alert Reports within three working days of identifying contamination — waiting over a year to file. FDA warned that failure to remediate may result in seizure, injunction, withholding of export certificates, and denial of new application approvals.
Required actions (4)
After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence.
Based upon the nature of the violations we identified at your firm, you should engage a consultant qualified as set forth in 21 CFR 211.34 to assist your firm in meeting CGMP requirements. The qualified consultant should also perform a comprehensive audit of your entire operation for CGMP compliance and evaluate the completion and efficacy of all identified corrective actions and preventive actions before you pursue resolution of your firm's compliance status with FDA.
Failure to promptly and adequately address this matter may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.
FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP.
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