Infupharma, LLC – FDA Warning Letter, Sep 27, 2011

This FDA Warning Letter to Infupharma, LLC, dated July 30, 2012, details significant Current Good Manufacturing Practice (CGMP) violations observed during a July-September 2011 inspection of their Hollywood, FL facility. The firm's repackaging of Avastin and HCG without prescriptions for resale was deemed to exceed traditional pharmacy practice, subjecting them to CGMP regulations (21 CFR Parts 210 and 211).

Violations include: 1. **Adulterated Products:** Avastin samples were found contaminated with *Streptococcus mitis/oralis* and other microorganisms, rendering products adulterated under Sections 501(a)(1) and 501(a)(2)(A) of the Act due to filth and insanitary conditions. 2. **CGMP Violations (501(a)(2)(B)):** * Lack of appropriate written procedures to prevent microbiological contamination (21 CFR 211.113(b)), including extended use of single-dose Avastin vials and inadequate aseptic process validation via media fills. * Failure to establish separate/defined areas to prevent contamination (21 CFR 211.42(c)(10)), evidenced by inadequate environmental monitoring, excessive supplies, and electrical cords in clean areas. * Inadequate personnel training and