AnazaoHealth Corporation
FDA issued a warning letter to AnazaoHealth Corporation, a Las Vegas-based 503B outsourcing facility, following a September 2019 inspection. The agency found that the facility's compounded drug products failed to meet section 503B conditions—specifically due to inadequate adverse event reporting procedures—rendering them ineligible for exemptions from FDA approval and labeling requirements. As a result, the products were deemed unapproved new drugs and misbranded under the FDCA. FDA demanded written corrective action within 15 working days and warned that failure to comply could result in seizure or injunction.
Flagged claims (2)
their labeling fails to bear adequate directions for their intended uses causing them to be misbranded under section 502(f)(1) of the FDCA
Marketing of these products, or other applicable products, without an approved application violates these provisions of the FDCA.
Required actions (2)
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to address any violations.
Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.
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