FDA WARNING_LETTER - Nephron Pharmaceuticals Corporation - April 20, 2022

On October 21, 2022, the FDA issued a Warning Letter to Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center, LLC, following an inspection from March 28 to April 20, 2022. The facility, registered as an outsourcing facility under section 503B of the FDCA, was found to have produced drug products that failed to meet 503B conditions and exhibited serious deficiencies in sterile drug production, posing patient risks.

Violations included compounding drug products using glycopyrrolate, a bulk drug substance not on the 503B bulks list or a drug shortage list, rendering these products ineligible for 503B exemptions from FDA approval, adequate directions for use, and Drug Supply Chain Security Act requirements.

The FDA also cited adulterated drug products due to insanitary conditions and CGMP violations. Specific issues included: - Failure to take appropriate corrective actions or perform adequate product evaluation after approximately 1686 microbial contamination excursions in the ISO 5 aseptic processing area. - Media fills not simulating challenging conditions, lacking assurance of aseptic production. - Failure to establish an adequate environmental monitoring system in aseptic processing areas (21 CFR 211.42(c)(10)(iv)). - Failure to conduct appropriate laboratory testing for objectionable microorganisms for each batch (21 CFR 211.165(b)).