FDA 483 - Pacifico National, Inc. dba AmEx Pharmacy - January 21, 2016

This FDA Form 483 was issued to Mark L. Sangree, President of Pacifico National Inc. dba Amex Pharmacy, an outsourcing facility located at 1515 Elizabeth Street, Suite J, Melbourne, FL 32901. The inspection occurred from January 12-15, 2016, and January 21, 2016.

The inspection revealed eleven observations:

1. **Inadequate Procedures for Preventing Microbiological Contamination:** Media fills for qualifying technicians in aseptic re-packaging of Avastin syringes were insufficient. They did not represent worst-case conditions (e.g., duration, breaks, gowning/re-gowning) and lacked proper observation by qualified personnel. Documentation for media fills was incomplete, missing details like units filled, environmental monitoring, and time duration, yet were approved.

2. **Deficient Aseptic Processing Area Cleaning and Disinfection:** The suitability and efficacy of disinfecting agents and procedures for ISO 5 & 7 classified areas were not assessed. A technician was observed removing and re-capping an Avastin vial stopper with gloved hands instead of a sterile tool.

3. **Deficient Aseptic Processing Area Air Supply:** Qualifications for the ISO 7 cleanroom and ISO 5 hoods did not document if performed under static or dynamic conditions with maximum personnel. Smoke studies were performed with fewer personnel than current practice.