FDA 483 - Zions Rx Formulations Services LLC dba Rx Formuations Serv. - January 09, 2014

This FDA Form 483 was issued to Zions RX Formulations Services LLC dba RX Formulations Serv., located at 5949 E University Dr, Mesa, AZ, a producer of sterile drug products. The inspection occurred from December 3, 2013, to January 9, 2014.

Eight observations were noted:

1. **Deficient Environmental Monitoring:** Aseptic processing areas lack adequate environmental monitoring. Specifically, there is no viable or non-viable particulate air monitoring during actual production in ISO 5 hoods and ISO 7 cleanrooms. Active monitoring of differential pressures in ISO 7 and ISO 5 environments is absent or not routinely recorded. Routine personnel monitoring for operators is not conducted after every lot, and surface sampling frequency for ISO 5 and ISO 7 environments is insufficient.

2. **Inadequate Microbiological Contamination Prevention Procedures:** Procedures to prevent microbiological contamination are not established. The firm does not always test sterilizing filters for drug products like Calcium Gluconate and lacks equipment for such testing. Components sterilized in-house via moist heat lack written procedures for use and maintenance, continuous temperature/pressure monitoring, and validation. Dry-heat depyrogenation of glass vials also lacks written procedures, continuous temperature/time monitoring, and validation.

3. **Lack of Finished Product Testing:** Each batch of sterile and pyrogen-free drug product is not consistently tested for conformance. For