FDA 483 - Revive Rx LLC dba Revive Rx Pharmacy - February 07, 2025

This FDA Form 483 details multiple observations from an inspection, primarily concerning the sterile manufacturing of drug products.

**Facility and Operations:** The firm produces sterile drugs, including Trimix Gel for Intraurethral Insertion and various injectable vials (e.g., Trimix, Bimix, FSH, Hexarelin, hCG, NAD+). Operations involve ISO 5, ISO 7, and ISO 8/7 areas, as well as unclassified areas.

**Violations and Observations:**

1. **Sterile Drug and Material Exposure to Sub-ISO 5 Air:** * Trimix Gel is prepared using non-sterile, uncapped syringes sterilized in an unclassified area. After sterilization, opened syringes are capped with "sterile" caps before transfer to ISO 8/7 and ISO 5 areas, lacking assurance of sterility maintenance in uncontrolled environments. * Drug product vials are transferred from an ISO 5 BSC through an ISO 7 area to a [redacted] within the ISO 7 area, exposing sterile products to air worse than ISO 5.

2. **Microbial Contamination:** * Failure to add routine environmental monitoring for mold, yeast, and spore-forming microorganisms in ISO 5 and ISO 7 areas. * Recoveries of *Paenibacillus glucanolyticus* (TNTC CFU) in ISO 7 prep cleanroom (01/