FDA 483 - Home Intensive Care Pharmacy, Inc. - March 01, 2013

The FDA Form 483 details multiple deficiencies at a facility producing sterile drug products, including intrathecal medications like Morphine/Bupivacaine.

**Violations and Observations:**

* **Aseptic Procedures:** The firm lacks written procedures for aseptic operations in ISO 5 and ISO 7 areas. A pharmacist was observed resting elbows on an ISO 5 laminar air-flow hood workbench and had exposed forearm skin due to a gap between non-sterile lab coat sleeves and sterile gloves during aseptic filling. * **Gowning Requirements:** Gowning procedures are inadequate and not formally documented for ISO 8, ISO 7, and ISO 5 areas. Observed gowning (single sterile gloves, non-sterile shoe covers, non-sterile lint-free lab coat, hair net, ear-loop face mask) left exposed skin around eyes, forehead, and neck during sterile drug processing. * **Facility and Equipment Design:** No evaluation of equipment contact surfaces or facility layout to prevent contamination in classified areas. ISO 5 laminar air-flow hood workbenches are made of particle board with a laminated surface. Smoke studies and pressure differential limits for ISO 5, ISO 7, and ISO 8 areas were only performed under static conditions, not dynamically. Pressure differentials between ISO 7 and ISO 8 are not actively monitored, and no limits are set; no apparent difference in pressure readings was observed, along with a spatial gap in the doorway between