Innoveix Pharmaceuticals Inc
FDA issued a warning letter to Innoveix Pharmaceuticals Inc. (Addison, TX) following a May 2021 inspection that found serious sterility and insanitary-conditions violations in the compounding of injectable peptide products, including Sermorelin/Ipamorelin and AOD-9604. The firm had already voluntarily recalled both products due to lack of sterility assurance. FDA cited multiple CGMP failures — including use of an unsuitable sterilization unit, improper aseptic technique, and use of household dish detergent on sterile glassware — constituting adulteration under FDCA section 501(a)(2)(A). The letter demands written corrective action within 15 working days and warns that failure to comply may result in seizure or injunction.
Flagged claims (4)
Your firm used household dish detergent to clean and sanitize glassware used in the production of sterile injectable drug products.
Your firm used an unsuitable (b)(4) unit to sterilize bulk drug solutions. The label on the (b)(4) unit states: "This product is not intended for use in direct patient care or diagnostic procedures."
Your firm used a non-sterile disinfectant within the ISO 5 aseptic processing area.
Your response also stated that you have not failed a sterility test in five years. However, a passing sterility test does not prove the sterility of each unit of each lot you produce and should not be solely relied upon as an indication of product sterility.
Required actions (3)
FDA acknowledges that on July 9, 2021, your firm voluntarily recalled compounded (b)(4) Semorelin/Ipamorelin 3 mg for subcutaneous or intramuscular injection and compounded (b)(4) AOD-9604, 3 mg for subcutaneous or intramuscular injection due to a lack of sterility assurance.
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. Please include an explanation of each step being taken to prevent the recurrence of any violations, as well as copies of related documentation.
Failure to adequately address this matter may result in legal action without further notice, including, without limitation, seizure and injunction.
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