AnazaoHealth Compounding Unapproved Drugs: FDA

A 9/9-9/19/19 FDA inspection at AnazaoHealth, Las Vegas, NV, found that drug products compounded at the facility don’t meet legal requirements for exemptions from the Federal Food, Drug, and Cosmetic Act for drugs produced by an outsourcing facility. An 8/18 Warning Letter says the facility does not comply with a requirement that requires an outsourcing facility to submit adverse event reports to FDA. “Specifically, your facility’s procedures for reporting adverse events are inadequate,” FDA says.

Because the compounded drug products don’t meet all applicable legal requirements, they are considered unapproved new drugs that are misbranded, the letter says.

FDA says it was unable to fully evaluate the firm’s proposed corrective actions.

AnazaoHealth was told to respond with a list of specific actions it has taken to correct the violations and prevent their recurrence, with related documentation and a schedule for completing the work.