FDA 483 - IV Solutions of Lubbock - March 20, 2013

The FDA Form 483 details multiple deficiencies observed during an inspection of a drug product manufacturing facility.

**Facility and Operations:** The facility processes drug products, including Vancomycin, Ceftriaxone, and Tobramycin Ampules for Inhalation, in an ISO 7 clean room with ISO 5 hoods.

**Violations and Observations:**

* **Personnel Gowning:** Personnel engaged in aseptic processing wore non-sterile hair covers, mouth covers, and gowns. On March 18 and 19, 2013, a technician in the ISO 5 Hood had exposed face, neck, and hair. Gowning worn outside the clean room did not completely cover clothing around the neck, below the knee, and backside. * **Building Construction:** The ISO 7 Clean Room's exhaust air vent is above the ISO 5 workbench level, potentially causing turbulent airflow. * **Airflow Verification:** No smoke studies were conducted to verify laminar airflow in ISO 5 Hoods. * **HEPA Filter Testing:** HEPA filters in the ISO 7 clean room and ISO 8 ante-room are not regularly leak tested; only visual checks and total airflow measurements are performed. No written procedure exists for HEPA filter certifications or frequency. * **Equipment Design:** An ISO 5 hood workbench has exposed wood laminate material around its edges, which is harder to disinfect than stainless steel. *