FDA WARNING_LETTER - ProRx, LLC - August 02, 2024

The FDA issued an Amended Warning Letter to ProRx, LLC, an outsourcing facility, after a July-August 2024 inspection revealed serious deficiencies in sterile drug production, leading to a voluntary recall due to sterility assurance concerns. ProRx ceased sterile production but plans to resume. Violations included failure to meet 503B conditions: compounding with bulk substances from an unregistered source, inadequate labeling (missing required statements and ingredient lists), and deficient adverse event reporting (21 CFR 310.305). These products thus lose 503B exemptions and are subject to new drug approval, adequate directions for use, and DSCSA requirements. Drug products were adulterated under section 501(a)(2)(A) due to insanitary conditions, including improper aseptic techniques, gowning issues, non-sterile wipes, inadequate media fills, no ISO 5 environmental monitoring, deficient smoke studies, and pest presence. Further adulteration under section 501(a)(2)(B) cited CGMP violations: failure to establish contamination prevention procedures (21 CFR 211.113(b)), inadequate environmental monitoring (21 CFR 211.42(c)(10)(iv)), an insufficient quality unit (21 CFR 211.22(a), 211.22(d)), and lack of stability testing (21 CFR 211.166(a)). Compounded drugs were also deemed unapproved new drugs (section 505(a)) and misbranded (section 502(f)(1)) due to inadequate directions for use. Many of ProRx's proposed corrective actions were found deficient, lacking documentation or scientific justification. The FDA strongly recommends a comprehensive third-party assessment. ProRx must respond within fifteen working days.