FDA 483 - Region Care, Inc. - March 20, 2014

This FDA Form 483 documents observations from an inspection, citing multiple deficiencies in the facility's operations related to sterile drug product compounding.

**Violations and Observations:**

* **Inadequate Investigations:** The firm failed to thoroughly investigate the sterility failure of Protonix 80mg/100ml 0.9% NaCl, lot # 19P-12125112-R6, compounded on 12/12/2013, without identifying a root cause or performing a risk evaluation. * **Environmental Monitoring Failures:** Failing gloved fingertip sampling results from a pharmacy technician on 12/11/2013, 12/20/2013, and 02/03/2014 were not investigated for root cause, risk, or CAPA. This technician also compounded the failed Protonix batch. * **Deficient Environmental Monitoring Program:** The EM program lacks daily surface/viable air sampling in ISO-5 areas during compounding, does not monitor non-viable particles in ISO-5 areas under dynamic conditions, and has no EM during media fills. Viable air and surface samples from ISO-5 LAFWs are not incubated/checked as required. Air-pressure differentials between ISO-6, ISO-7, and unclassified areas are not monitored, despite manometers being present. * **