FDA 483 - California Pharmacy & Compounding Center - October 17, 2014

On October 14-17, 2014, the FDA inspected California Pharmacy & Compounding Center, an outsourcing facility located at 4000 Birch St Ste 120, Newport Beach, CA. The inspection revealed several violations.

**Observation 1:** The firm failed to thoroughly review unexplained discrepancies and batch failures. Specifically, investigations were not conducted for patient adverse drug event (ADE) complaints. For instance, a patient developed endophthalmitis after receiving repackaged Avastin syringes (Lot: B082614A) on August 26, 2014, but compounding records were not reviewed, nor were other related lots investigated. Similarly, three ADE complaints (ADE-1, ADE-2, ADE-3) on May 16, 2014, linked to Bevacizumab (Avastin) 1.25mg/0.05ml (Lot: B051614A) causing endophthalmitis, were not investigated for connection to the implicated lot.

**Observation 2:** Written records of investigations into batch failures lacked conclusions and follow-up. Microbial growths were observed on employee gloves, sterile face shields, and sterile gowns on multiple dates in October 2014, with no investigation reports completed or microbial identification performed. Root cause corrective or preventive actions were not implemented, deviating from the firm's procedure #A