Home Intensive Care Pharmacy, Inc. – FDA 483, May 5, 2015

The FDA Form 483 details multiple deficiencies at a facility producing sterile drug products, including Bupivacaine/Lidocaine, Morphine/Clonidine, Vancomycin, Baclofen, Hydromorphone/Clonidine, and Fentanyl.

Key violations include: 1. **Sterilization Process Validation:** Media fills do not adequately simulate actual production conditions, including various vial/syringe sizes and batch sizes. Syringe production is not assessed in current media fill validations. The incubator used for media fills lacks a written procedure for use/maintenance and temperature monitoring records. 2. **Environmental Monitoring:** No written procedure for environmental monitoring of ISO 5 areas. Monitoring of ISO 5 laminar flow hoods and ISO 7 cleanroom is not performed during production. Viable air monitoring in ISO 7/ante/prep rooms is only done during certification, not routinely. ISO 5 laminar flow hoods lack viable air monitoring. Operator fingertip sampling is infrequent. 3. **Cleaning and Disinfection:** Non-sterile wipes are used in ISO 5 laminar flow hoods. A sporicidal disinfectant is not used in ISO 5/ISO 7 areas. Components are not sprayed with disinfectant before entering ISO 5 hoods. 4. **Personnel Gowning:** Gowning attire (scrubs donned outside, non-sterile lab coat, single hairnet, ear-loop mask) leaves exposed skin. Specific observations include a torn