AnazaoHealth Corporation – FDA 483, Feb 22, 2013

The FDA Form 483 details numerous deficiencies at a facility producing sterile drug products, specifically for Pain Management and Nuclear preparations.

**Key Violations and Observations:**

* **Sterility Assurance & Validation:** * Media fills for Pain Management products do not simulate actual production (e.g., non-sterile media preparation in uncontrolled areas, open media exposed to disinfectants, no growth promotion tests, no environmental monitoring during fills, sterilizing filter removal for medium-risk products, lack of worst-case conditions). * High-volume media fills are similarly deficient, using incorrect vial sizes and lacking proper sterilization for production vials/stoppers. * Sterilization parameters for autoclaves are not established, written, or readily available. * Technicians used incorrect sterilization parameters for utensils. * Sterile supplies (glassware, utensils) were observed with stains, tears, and lacked sterilization dates. * Sterile bottles were refilled with non-sterile solutions in-house without obliterating original labels, leading to confusion. * Components disinfected with spray were wiped with dirty rags. * Supplies lacked unique load/batch numbers and sterilization dates, raising concerns about the use of supplies from failed or expired runs. * Sterilization processes for products from non-sterile components are not validated, and pre-filtration bioburden limits are not established. * Ster