FDA 483 - AnazaoHealth Corporation - March 24, 2017

This FDA Form 483 details multiple observations from an inspection of an outsourcing facility.

**Facility and Operations:** The facility compounds drug products, including sterile injectables (e.g., Testosterone Cypionate, MIC with Cyanocobalamin, Methylcobalamin) and sterile pellets (e.g., Testosterone, Testosterone/Anastrozole, Estradiol).

**Violations and Observations:**

1. **Inadequate Sterilization Process Validation:** * Failure to maintain established sterilizing and depyrogenation parameters during November 2016 re-qualification of (b)(4) for 5mL glass vials and (b)(4) drug solution. * Lack of scientific justification for using (b)(4) Sterilization Validation method for compounded drug products, specifically for pharmaceutical pellets, and its specificity for these products. * Sterile pellet drug product batches produced for (b)(4) are not representative of routine manufacturing batches (e.g., (b)(4) vs. (b)(4) routine batches). * Media fill batch (b)(4) was observed in an unmonitored hallway, lacking temperature data to confirm appropriate incubation.

2. **Failure to Reject Non-Conforming Products:** * Visual inspection failures: On 3/16/2017, Pharmacy Technician (b)(6) performed visual inspection for 1