FDA 483 - AnazaoHealth Corporation - July 29, 2022

The FDA Form 483 details significant deficiencies at a drug manufacturing facility, impacting multiple drug products including Testosterone Cypionate, Estradiol, (b)(4) Nutrient Cocktail, and Thiamine HCl/Pyridoxine HCl injections, produced in the (b)(4) and (b)(4) Suites.

Key violations include: 1. **Lack of Quality Unit Authority:** The quality unit lacks authority to review production records and fully investigate errors. Sterility test data packets from the contract laboratory have not been reviewed for batch release since January 20, 2015, for the (b)(4) Suite and since August 2020 for the (b)(4) Suite. 2. **Absence of Written Production/Process Controls:** No written procedures exist to assure drug product identity, strength, quality, and purity. Validation for Testosterone and Estradiol implantable pellets lacked sufficient sampling for statistical confidence of uniformity and failed to demonstrate constant hormone release over time, instead showing immediate release characteristics. 3. **Inadequate Batch Failure Investigations:** The firm failed to thoroughly review batch failures. Approximately 26 adverse event reports for Testosterone and Estradiol implantable pellets (including death, heart attack, stroke, embolism, and breast cancer) between November 2019 and March 2022 were not adequately investigated, lacking additional testing or determination of product causation. A sterility failure for (b)(4) Nutrient