FDA 483 - Option Care Enterprises - February 08, 2018

This FDA Form 483 documents observations from an inspection concerning sterile drug production. The facility was observed performing aseptic manipulations for (b)(4) bags for Rx (b)(6) SN (b)(4) TPN (b)(4) 4mL.

Two primary violations were noted regarding poor aseptic practices: 1. **Direct Contact and Air Impeding:** On January 25, 2018, a technician performing a (b)(4) addition of sodium acetate 2 meq/mL to a TPN sterile drug product bag placed a gloved finger directly on the unprotected junction between the uncapped injection port of the TPN bag and the syringe hub. This contact impeded first air to the junction during the addition. 2. **Contaminated Syringe:** The same day, after removing air from bag (b)(4), the uncapped syringe needle touched the surface of the ISO 5 cabinet. This same syringe and needle was subsequently used to remove air from bag (b)(4) of the same formulation.

Additionally, the inspection found that disinfecting agents, cleaning pads, and cleaning wipes used for sterile drug production were not always sterile or controlled to maintain sterility: 1. **Non-Sterile Wipes:** The firm uses (b)(4) wipes, labeled in part (b)(4), to disinfect the exterior of equipment, components, and container/closures before placement into ISO 5 cabinets during aseptic