FDA 483 - Revive Rx LLC dba Revive Rx Pharmacy - August 06, 2021

This FDA Form 483 was issued to Revive Rx, LLC dba Revive Rx Pharmacy, located at 3831 Golf Drive Suite A, Houston, TX 77018. The inspection, conducted from July 20 to August 6, 2021, identified the firm as a producer of sterile and non-sterile drug products. Mr. Aaron M. Schneider, Director of Operations and co-owner, was the recipient of the report.

Five observations were noted: 1. **Inadequate ISO 5 area certification:** Smoke studies were not performed to demonstrate unidirectional airflow and sweeping action over sterile drug products under dynamic conditions. 2. **Ineffective depyrogenation:** The methods used for depyrogenation of product/equipment intended to be sterile were not lethal to heat-resistant microorganisms. Specifically, endotoxin indicators were not used to verify the adequacy of the depyrogenation process for glassware used in sterile injectable products. 3. **Insufficient media fills:** Media fills did not closely simulate aseptic production operations, failing to incorporate worst-case activities and conditions. Media fills were not representative of actual production processes, such as the typical lot size for Human Chorionic Gonadotropin 12,000 IU Vial for Injection, and did not evaluate the transfer of vials to and from the ISO 5 hood. 4. **Exposure of sterile product to lower quality air:**