FDA 483 - Central Admixture Pharmacy Services, Inc. - August 22, 2018

This FDA Form 483 was issued to Central Admixture Pharmacy Services, Inc., an Outsourcing Facility located at 6580 Snowdrift Rd Ste 100, Allentown, PA 18106-9331. The inspection occurred from July 30, 2018, to August 22, 2018. David L. Cain, Operations Manager, received the report.

Eight observations were noted:

1. **Deficient Aseptic Processing Areas:** The ISO-7 cleanroom design and operations are cluttered, requiring personnel to maneuver awkwardly and handle paper within the ISO-5 space. Labeling and printing occur in the cleanroom, and components for future shifts are stored there during operations. 2. **Inadequate Microbiological Contamination Prevention:** Procedures for disinfecting and introducing materials into the cleanroom do not ensure established dwell times, and the disinfection solution preparation and monitoring are insufficient. Operators handle paper labels and apply them to products within the ISO-5 workbench without sanitizing gloves. Sterile connection manipulations by operators block first-pass air. 3. **Deficient Environmental Monitoring:** Environmental monitoring is not representative of conditions, with sampling only during one shift despite multi-shift operations. Viable and non-viable particulate monitoring of ISO-5 workbenches is not always performed correctly or while operators are present, and hard-copy raw data is not retained. Non-viable particulate