FDA 483 - AnazaoHealth Corporation - September 19, 2019

During an FDA inspection, deficiencies were noted in the aseptic processing areas and material flow at a sterile compounding outsourcing facility.

**Violations and Observations:**

1. **Aseptic Processing Area Cleaning and Disinfection:** * The firm lacks a visual inspection requirement to verify the completion and effectiveness of cleaning for classified laminar flow hoods/biosafety cabinets and cleanrooms. * During a walk-through on September 9th, despite being informed rooms were in "clean status": * Accumulated cleaning residue was found in LFH (b)(4) Cleanroom (b)(4). * Small cracks/fractures were observed in the (b)(4) side paneling of LFHs (b)(4) and (b)(4). * A small piece of plastic (1/2-inch x 1/8 inch) was stuck in the (b)(4) front grill of BSC (b)(4) Cleanroom (b)(4). * A 2-inch string of Teflon tape was dangling from a (b)(4) inside BSC (b)(4) Cleanroom (b)(4).

2. **Material Flow and Contamination Prevention:** * The flow of components, drug product containers, closures, and in-process materials through the building is not designed to prevent contamination. * Specifically, (b)(4) in