Farmakeio Outsourcing LLC
FDA issued a warning letter to Farmakeio Outsourcing LLC (Southlake, TX), a 503B-registered outsourcing facility, following a 2019 inspection that found the facility's compounded drug products failed to meet section 503B conditions. Key violations included inadequate adverse event reporting procedures, compounding testosterone pellets that may constitute essentially a copy of an approved drug (Testopel), and distributing unapproved new drugs and misbranded products lacking adequate directions for use. FDA demanded written corrective action within 15 working days and warned that failure to comply could result in seizure or injunction.
Flagged claims (4)
You do not have any FDA-approved applications on file for drug products that you compound.
your facility compounded Testosterone Pellets in 12.5 mg, 25 mg, 37.5 mg, 50 mg, 62.5 mg, 87.5 mg, 100 mg, and 200 mg strengths using the bulk drug substance Testosterone
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 SOP does not adequately define a serious adverse event consistent with the definition of serious adverse drug experience in 21 CFR 310.305(b)
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.
Should you continue to compound and distribute drug products that do not meet the conditions of section 503B, the compounding and distribution of your drugs would be subject to the new drug approval requirement, the requirement to label drug products with adequate directions for use, and the Drug Supply Chain Security Act requirements.
Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.
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