GenoGenix LLC
GenoGenix LLC, a compounding outsourcing facility in Boca Raton, FL, received an FDA Warning Letter following a July 2025 inspection that uncovered pervasive CGMP violations, sterility failures, and use of ineligible bulk drug substances including 5-Amino-1MQ, NAD+, and Thymosin Beta-4. The facility also repackaged unapproved new drugs including Semaglutide, Tirzepatide, and Retatrutide without FDA-approved applications, and released products with sub-labeled potency and excessive bacterial endotoxins that sent three patients to the emergency room. FDA required a written response within 15 working days and warned that failure to adequately address violations may result in seizure and injunction; the firm had already voluntarily ceased production and initiated a recall.
Flagged claims (9)
Thymosin Beta-4
an unopened vial from the same lot was found to contain excessive bacterial endotoxins with a reported value of 3,360 EU/mL
Immune Defense Nasal Spray
Rapamycin, Clear Mind 150, and LIPO (MIC) + B
injectable B Complex, which was determined to have 43.1% the amount of dexpanthenol listed on the label
Glutathione Magnesium, Reconstitution Solution, and Epithalon
injectable methylcobalamin 5,000 mcg/mL, which was determined to have 65.3% the amount of methylcobalamin listed on the label
5-amino-1-methylquinolinium iodide (5-Amino-1MQ) and nicotinamide adenine dinucleotide (NAD+)
Semaglutide, Tirzepatide, and Retatrutide
Required actions (5)
FDA acknowledges that your firm has ceased drug production and distribution. FDA also acknowledges that on July 30, 2025, your firm initiated a voluntary recall of drug products intended or expected to be sterile, within expiry, due to lack of sterility assurance or microbial contamination.
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to address any violations, or you may inform us that you do not intend to resume production of drugs.
If you intend to resume production of drugs, please include an explanation of each step being taken to prevent the recurrence of any violations, as well as copies of related documentation.
you should notify this office fifteen (15) working days prior to resuming production of any drugs.
Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.
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