8046255 Canada Inc. – FDA Warning Letter, Sep 24, 2019

On June 11, 2020, the FDA issued a Warning Letter to 8046255 Canada Inc., dba Viatrexx, following an inspection from September 16-24, 2019, at their Beloeil, QC facility. The letter cited significant violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR parts 210 and 211) for finished pharmaceuticals, rendering their drug products adulterated.

Key violations include: 1. **Failure to prevent microbiological contamination (21 CFR 211.113(b)):** The firm manufactured sterile injectable homeopathic products without validating aseptic processes. This involved inadequate media fills, using an unsuitable (b)(4) filter for sterile filtration without post-use integrity testing, and poor aseptic techniques observed during operations. The firm's recall and proposed corrective actions were deemed insufficient. 2. **Inadequate personnel gowning (21 CFR 211.28(a)):** Non-sterile and re-used gowning materials were used for aseptic operations, with exposed facial skin and bare hands observed. Proposed sterile gowning was still inadequate. 3. **Failure to monitor environmental conditions and ensure adequate cleaning/disinfection (21 CFR 211.42(c)(10)(iv) and (v)):** Cleaning/disinfection procedures were inadequate,