FDA 483 - Brookfield Prescription Center Inc. dba MD Custom Rx - December 13, 2013

This FDA Form 483 details inspectional observations made at Monica M. Zatarski PharmD, RPh, Compounding Pharmacist, Owner and President's facility in Minneapolis, MN, during inspections conducted from December 3-13, 2013.

**Key Observations and Violations:**

1. **Microbiological Contamination Prevention:** Procedures for preventing microbiological contamination of sterile drug products are not established, written, or followed. * SOP 9.110 (Sterile Compounding Process Validation/Media Fills) is inadequate and does not reflect actual practices (e.g., media fills not simulating actual compounding activities, technician filling 100 vials at 3.5 mL vs. 10 mL qualification, non-representative interventions). * Sterilization processes are not validated, despite SOP 3.1112 requiring biological indicators for each load.

2. **Failure to Review Batch Failures:** The firm failed to thoroughly review batches or components not meeting specifications. * SOP 6.201 (Potency Testing) requires OOS investigation and recall determination, but a formal OOS investigation for Glycopyrrolate injection (notified Nov 12, 2013) had not been initiated by Dec 3, 2013. * Four OOS investigations since January 2013 did