Annovex Pharma, Inc.
FDA issued a warning letter to Annovex Pharma, Inc. (Lorton, VA), a 503B outsourcing facility, following an August–September 2024 inspection that revealed serious CGMP violations and failure to meet section 503B conditions. The facility produced sterile drug products under insanitary conditions — including failing to investigate positive microbial growth in 10% of media fill units — and failed to submit required biannual drug product reports and adequate adverse event reporting procedures. As a result, the compounded drug products were deemed adulterated, misbranded, and unapproved new drugs, with FDA warning that failure to remediate may result in seizure or injunction.
Flagged claims (5)
Your firm failed to perform adequate smoke studies under dynamic conditions to demonstrate unidirectional airflow within the ISO 5 area.
Your media fills were not performed under the most challenging or stressful conditions. In addition, your firm continued to produce and distribute drug products intended to be sterile despite positive growth being identified in 10% of filled units during your January 2024 media fill.
You do not have any FDA-approved applications on file for drug products that you compound.
their labeling fails to bear adequate directions for their intended uses causing them to be misbranded under section 502(f)(1) of the FDCA
your facility failed to submit a report to FDA in June 2024 identifying the drug products that you compounded during the previous 6-month period
Required actions (3)
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.
FDA strongly recommends that your management undertake a comprehensive assessment of operations, including facility design, procedures, personnel, processes, maintenance, materials, and systems. In particular, this review should assess your aseptic processing operations. A third party consultant with relevant sterile drug manufacturing expertise should assist you in conducting this comprehensive evaluation.
Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.
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