Central Admixture Pharmacy Services, Inc. – FDA 483, Feb 11, 2015

The FDA Form 483 details multiple deficiencies at a facility producing sterile drug products, specifically Oxytocin and TPN.

**Sterilization Process Validation:** The sterilization process for REDACTED used in Oxytocin compounding lacks adequate validation to ensure sterility for the batch duration. This REDACTED can compound over REDACTED units, with over REDACTED Oxytocin lots produced in January 2015.

**Gowning Qualification:** The gowning qualification program (SOP-CAPS-4000516, version 7.0) for operators in ISO5/ISO7 areas is inadequate. Surface monitoring sites on personnel do not cover all potential contact points with ISO 5 production areas, as observed on 2/5/2015, where an operator leaned into ISO 5 hoods with unmonitored body parts.

**Sterility Testing:** The alternate sterility testing method, REDACTED, used for product release is inadequate. It has a maximum sample capacity of REDACTED, sampling only REDACTED of 1000ml Oxytocin products, compared to 10% or more specified in USP <71> Sterility Test. For lots of 100 units or more, 10 units should be tested, but over REDACTED Oxytocin lots in January 2015 were released using this method. The REDACTED method's equivalency to USP <71