FDA 483 - Inventive Infusion Solutions, LP - August 31, 2018

This FDA Form 483 was issued to Ernesto F. Garza-Gongora, Pharmacist-In-Charge and Owner of Inventive Infusion Solutions, LP, located at 18866 Stone Oak Pkwy Ste 101a, San Antonio, TX 78258-4181. The inspection, conducted from August 20-31, 2018, identified several observations at this producer of sterile and non-sterile drugs.

Key observations include: 1. **Improper Use of Biological Indicators:** Biological indicators are not used to verify the adequacy of the sterilization cycle for pellet drug products like Testosterone 75 mg, as BIs are not subjected to the same conditions as the pellets. 2. **Lack of Endotoxin Testing:** Endotoxin levels are not tested on finished intrathecal drug products, which are made from non-sterile starting materials, nor on bulk drug substances, providing no assurance of safety. 3. **Use of Non-Sterilized/Non-Depyrogenated Equipment:** Glassware and equipment, purportedly depyrogenated in an unclassified area, are stored indefinitely without established hold times, and then used in sterile drug production (e.g., Hydroxyprogesterone Caproate, HCG, LIPO B Injections). 4. **Inadequate Media Fills:** Media fills do not simulate aseptic production operations by