FDA 483 - AnazaoHealth Corporation - March 24, 2017

The FDA Form 483 details multiple deficiencies at a compounding facility.

**Facility and Operations:** The facility produces sterile injectable drug products, including Testosterone Cypionate, MIC with Cyanocobalamin, Methylcobalamin, and compounded pellet products like Testosterone, Testosterone/Anastrozole, and Estradiol.

**Violations and Observations:**

* **Sterilization Process Validation:** Procedures for preventing microbiological contamination lack adequate validation. Re-qualification of sterilizing and depyrogenation processes failed to meet established protocol criteria (e.g., November 2016 Depyrogenation for 5mL glass vials and drug solution). * **Microbiological Testing:** Batches of drug product required to be free of objectionable microorganisms are not tested through appropriate laboratory testing. * **Sterilization Method Justification:** Lack of scientific justification for using the Sterilization Validation method (ISO 11737 parts) for compounded pellet products, and sterile pellet batches are not representative of routine manufacturing (e.g., validation batches of 100 vs. routine batches up to 10,000). * **Product Rejection:** Drug products failing to meet specifications are not rejected. Examples include: * On 3/16/2016, 2 out of 9 MIC with Cyanocobalamin vials and 4 out of 25 Testosterone Cypionate vials with particles were