FDA 483 - PharMerica LLC - February 23, 2017

This FDA Form 483 was issued to Mr. Robert Kulak, R.Ph., Director of Pharmacy at PharMerica LLC, located at 6330 E. 75th St. Suite 322, Indianapolis, IN 46250. The inspection of this producer of sterile drug products occurred on February 6-9, 21, and 23, 2017.

The inspection revealed eight observations:

1. **Personnel Aseptic Technique Deficiencies:** Technicians were observed with exposed bare hands in the ISO 5 environment while donning sterile gloves and wearing non-sterile gowns with sleeves exposed to the ISO 5 environment during production of prescription number (b)(6) and ondansetron 2mg/ml batch B:36222. 2. **Manipulation of Sterile Components Outside ISO 5:** A technician opened sterile syringe caps in the ISO 7 area before placing them in the ISO 5 hood for filling ondansetron 2mg/ml batch B:36222. 3. **Non-Sterile Disinfecting Agents and Wipes:** The (b)(4) solution and (b)(4) used for sanitizing cleanrooms and materials were not labeled as sterile. Wipes used in ISO 5, 7, and 8 areas were not labeled as sterile or low lint/shed, and