FDA 483 - Pharmedium Services, LLC - September 24, 2015

The FDA Form 483 details multiple deficiencies at a drug product manufacturing facility.

**Facility and Operations:** The firm produces sterile drug products, including Norepinephrine, Magnesium Sulfate, Vancomycin HCl, and Oxytocin.

**Violations and Observations:** 1. **Aseptic Technique Failure:** On 08/24/2015, a pharmacist placed their head inside an ISO 5 Laminar Air Flow hood while collecting Norepinephrine 4mg 250 ml, 5% Dextrose Injection, USP (Lot 15236112S), violating SOP CPS-305, Version 13.0, which prohibits leaning into or against the hood. 2. **Deficient Sterility and Endotoxin Testing:** The firm failed to perform sterility and endotoxin testing on each lot of sterile drug product prior to release and distribution, only testing a fraction of products. Examples include Norepinephrine (Lot 15236112S), Magnesium Sulfate (Lot 15237091S), Vancomycin HCl (Lot 15238397S), and Oxytocin (Lot 15237111S), all shipped prior to sterility testing. 3. **Deficient Potency Testing:** Potency testing was not performed on each lot of drug product prior to release and distribution, only on a fraction