FDA 483 - SCA Pharmaceuticals, Inc. - September 29, 2017

An FDA inspection of SCA Pharmaceuticals, LLC, an outsourcing facility located at 8821 Knoedl Ct, Little Rock, AR, was conducted from September 25-29, 2017. The inspection, led by Investigators Nimmy Mathews and Claire M Minden, identified six observations.

Key deficiencies include: 1. **Environmental Monitoring:** Aseptic processing areas exhibited deficient environmental monitoring, with 22 instances of exceeding action levels in ISO 5 laminar flow hoods since January 2017, including 7 air samples with various microbial contaminants like *Aeromicrobium fastidiosum* and *Staphylococcus epidermidis*. 2. **Discrepancy Review:** The firm failed to thoroughly review unexplained discrepancies, continuing to release products despite meeting or exceeding action limits. 3. **Personnel Gowning:** Personnel clothing was inappropriate for aseptic duties; an individual had exposed neck skin between the mask and hood during operations on September 25, 2017. 4. **Sterilization Validation:** Procedures to prevent microbiological contamination lacked validation of the sterilization process. 5. **Aseptic Equipment Maintenance:** Systems for maintaining equipment in aseptic conditions were deficient. Observations included uncleaned wheels on carts and chairs, improper cleaning techniques (not cleaning back to front, left to right), gowns touching previously cleaned areas, and failure to change wipes after each wipe. 6. **Product