Kevin P. Hogan
President & Owner
Innoveix Pharmaceuticals Inc
3790 Arapaho Road
Addison , TX 75001-4311
United States
innoveix@gmail.comFEI 3012907473Issued Jan 26, 2022Office of Pharmaceutical Quality Operations, Division II
Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3012907473.
Violations0
Issue DateJan 26, 2022
Product TypeDrugs
StatusOpen
Letter Details
Firm
Innoveix Pharmaceuticals Inc
Location
Kevin P. Hogan
President & Owner
Innoveix Pharmaceuticals Inc
3790 Arapaho Road
Addison , TX 75001-4311
United States
innoveix@gmail.com
FEI Number
3012907473
Country
United States
Issue Date
January 26, 2022
Issuing Office
Office of Pharmaceutical Quality Operations, Division II
Product Type
Drugs
Status
Open
Summary
Innoveix Pharmaceuticals Inc was cited for manufacturing adulterated sterile drug products, including compounded Semorelin/Ipamorelin and AOD-9604 injectable formulations, in violation of the Federal Food, Drug, and Cosmetic Act. The FDA inspection from May 2021 identified serious deficiencies in sterile drug production practices, including the use of unsuitable sterilization equipment for bulk drug solutions that created contamination risks. The company voluntarily recalled the affected products in July 2021 due to lack of sterility assurance, acknowledging the inadequacy of their manufacturing controls.
Innoveix Pharmaceuticals Inc FDA Warning Letter, January 26, 2022
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