Innoveix Pharmaceuticals Inc – FDA Warning Letter, May 27, 2021

The FDA inspected Innoveix Pharmaceuticals, Inc. from May 11-27, 2021, identifying serious deficiencies in sterile drug product production, leading to a Form FDA 483. The firm voluntarily recalled compounded Semorelin/Ipamorelin 3 mg and AOD-9604, 3 mg due to lack of sterility assurance.

The FDA found drug products adulterated under FDCA Section 501(a)(2)(A) due to insanitary conditions. Violations included using an unsuitable unit for sterilization without post-use testing, exposing sterile vials to less than ISO 5 quality air, an operator blocking first air, using an unclean and unprotected unit, inadequate media fills, using household dish detergent for glassware, and using non-sterile disinfectant in the ISO 5 area.

The firm's response to the FDA 483 was reviewed. While some corrective actions were deemed adequate, others lacked sufficient documentation (e.g., future sterilization methods, post-use testing). Deficient corrective actions included not discarding impacted vials after first air was blocked, insufficient actions to prevent future aseptic technique lapses, unsubstantiated claims about the self-cleaning nature of a unit, and inadequate media fill simulations.

The FDA recommends a comprehensive assessment of operations, including facility design, procedures, personnel, processes, maintenance, materials, and systems, with assistance from a third-party consultant. The firm must respond within fifteen working