# FDA WARNING_LETTER - Innoveix Pharmaceuticals Inc - May 27, 2021

Source: https://www.globalkeysolutions.net/records/warning_letter/innoveix-pharmaceuticals-inc/a95b834c-c4dd-4668-a0ee-ed3b65e70038

> FDA WARNING_LETTER for Innoveix Pharmaceuticals Inc on May 27, 2021. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Innoveix Pharmaceuticals Inc
- Inspection Date: 2021-05-27
- Product Type: Drugs
- Office Name: Office of Pharmaceutical Quality Operations Division I
- Summary: 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

## Related Officers

- [Dan Lype](https://www.globalkeysolutions.net/people/dan-lype/4a8c8a19-1584-4a5a-8b3b-97b5aced995c)
- [Program Division Director](https://www.globalkeysolutions.net/people/monica-r-maxwell/e1b3373a-80b0-4023-9aea-b4ac7170c964)

Company: https://www.globalkeysolutions.net/companies/innoveix-pharmaceuticals-inc/6fcf1227-2395-40f9-a984-299c4b4dfadb

Office: https://www.globalkeysolutions.net/offices/office-of-pharmaceutical-quality-operations-division-i/798d6a62-d1f1-4f7c-8de3-465e277c13da