FDA 483 - AnazaoHealth Corporation - August 08, 2025

**FDA 483 Summary for AnazaoHealth Corporation**

**Inspection Dates:** July 28, 2025, to August 8, 2025 **Location:** Las Vegas, NV **Facility Type:** Outsourcing Facility **Individual Addressed:** Douglas F. Cammann, Vice President of Operations

**Key Observations and Issues:**

1. **Production and Process Controls:** AnazaoHealth failed to establish adequate written procedures to ensure drug products meet identity, strength, purity, and quality standards. Specifically, the firm did not assess pellet-to-pellet content uniformity and did not validate compression speed as a controlled parameter, leading to potential quality inconsistencies.

2. **Microbiological Contamination Prevention:** The firm lacked proper procedures to prevent contamination in sterile drug products. Observations included exposure of sterile packaging to non-sterile environments and inadequate validation of hold times for depyrogenized equipment, risking sterility and product integrity.

3. **Complaint Handling:** The firm"s complaint investigations were inadequate, lacking retain sample testing for quality-related adverse events. This deficiency was noted in cases involving testosterone pellets and Ascorbic Acid, where potential sterility and quality issues were not thoroughly evaluated.

4. **Laboratory Records:** Laboratory records were incomplete, failing to include necessary data for compliance assurance. The firm did not test individual pellets for content uniformity or perform hardness testing, compromising the assurance of product consistency and quality.

**Regulatory Framework:** These observations are reported under the FD&C Act Section 704(b) to assist AnazaoHealth in achieving compliance.

**Required Actions:** AnazaoHealth must address these deficiencies by implementing corrective actions, including establishing robust process controls, enhancing contamination prevention measures, improving complaint investigation procedures, and ensuring comprehensive laboratory testing and documentation.