FDA 483 - AnazaoHealth Corporation - September 23, 2024

The FDA Form 483 documents observations from an inspection, highlighting three key areas of concern.

**Observation 1** details issues with investigations into unexplained discrepancies and out-of-specification (OOS) results for drug products. Specifically, on April 12, 2024, the control testing laboratory for human sterile drug product PlenishIV Nutrient Cocktail lot #(b)(4) J found superpotent riboflavin results (130.2%) with "different peaks" in the chromatogram. Instead of investigating, a new "standard" was used to re-analyze and obtain in-specification results, which were then relied upon for release. Similarly, on April 18, 2024, subpotent Pyridoxine HCI results were found for three lots of PlenishIV Nutrient Cocktail (lots #(b)(4) 7 and [(b)(4)n). A preliminary investigation concluded incorrect sample preparation by an analyst without scientific rationale. New samples were prepared, yielding in-specification results, which were used to invalidate original OOS results and release the lots.

**Observation 2** addresses inadequate container closure systems. The firm has not ensured the integrity of glass inserts in the container closure system for implantable pellets during shipment and storage. Between October 31, 2022, and June 19, 2024, eight complaints were received regarding glass fragments found inside the pellet container closure system