FDA WARNING_LETTER - Franck's Lab Inc., d.b.a. Franck's Compounding Lab - May 11, 2012

On July 9, 2012, the FDA issued a Warning Letter to Franck's Lab, Inc. dba Franck's Compounding Lab following a March 9 - May 11, 2012 inspection. The inspection revealed significant violations related to the compounding of sterile drug products, particularly Brilliant Blue G (BBG) Injection and Triamcinolone Injection.

The BBG Injection was found to be adulterated under sections 501(a)(1) and 501(c) of the Act due to the presence of *Fusarium incarnatum-equiseti species complex* and other microorganisms, genetically matching clinical isolates from patients who developed fungal endophthalmitis. All sterile drugs compounded by the firm were also adulterated under section 501(a)(2)(A) due to insanitary conditions. The BBG Injection was further misbranded under Section 502(a) because its labeling claimed sterility despite contamination.

Specific insanitary conditions observed included: a technician re-entering the cleanroom without changing PPE, a technician touching the outside of sterile gloves with a bare hand before compounding, and a technician touching the hood's outer surfaces (known to be contaminated) before sterile compounding.

Additional deficiencies noted were: inadequate assessment of compounding personnel aseptic practices (e.g., no fingertip sampling), failure to use fungal growth media for environmental monitoring, lack of environmental viable airborne particle testing under