FDA 483 - SterRx, LLC - June 28, 2023

The FDA Form 483 inspection revealed multiple deficiencies at a facility manufacturing sterile drug products in Blow-Fill-Seal (BFS) IV bags.

**Facility and Operations:** The facility produces sterile drug products, including 150 MEQ Sodium Bicarbonate D5W Injection and 0.2mg Fentanyl/0.125% Bupivacaine in 0.9% Sodium Chloride, using BFS (Equipment # E0581), Capper (Equipment # E0602), and Bag Filling/Sealing Machine (Equipment # E0655).

**Violations and Observations:** * **Contamination Prevention (21 CFR 211.80(b)):** Failure to maintain sterility of the cap and interstitial space of BFS IV bags, which cannot be sanitized by the user. * **Protective Apparel (21 CFR 211.28(a)):** An operator in non-sterile garb (hood, face mask, safety glasses, coverall) entered the ISO 5 space during an intervention on 06/02/2023, with exposed skin around safety glasses and hood/mask borders. * **Environmental Monitoring (21 CFR 211.42(c)(10)(iv)):** The environmental monitoring program for BFS and Capper lacks direct monitoring of caps during transfer to the capping/sealing