Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center, LLC
FDA issued a warning letter to Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center, LLC, a registered 503B outsourcing facility in West Columbia, SC, following a March–April 2022 inspection that revealed serious sterility assurance failures, including approximately 1,686 microbial contamination excursions in ISO 5 aseptic processing areas and inadequate media fills. The facility also compounded drug products using glycopyrrolate, a bulk drug substance not on the 503B bulks list and not on the drug shortage list, rendering those products ineligible for 503B exemptions and subject to unapproved new drug and misbranding violations. FDA acknowledged two voluntary recalls initiated by the firm but found corrective action responses inadequate in several respects. The letter warns that failure to address violations may result in seizure and injunction.
Flagged claims (3)
drug products intended or expected to be sterile were prepared, packed, or held under insanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health
their labeling fails to bear adequate directions for their intended uses causing them to be misbranded under section 502(f)(1) of the FDCA
your facility compounded drug products using glycopyrrolate. Drug products compounded using this bulk drug substance are not eligible for the exemptions provided by section 503B, because it does not appear on the 503B bulks list, and is not used to compound a drug that appears on the drug shortage list.
Required actions (3)
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to address any violations.
Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.
FDA strongly recommends that your management undertake a comprehensive assessment of operations, including facility design, procedures, personnel, processes, maintenance, materials, and systems. In particular, this review should assess your aseptic processing operations.
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