FDA 483 - First Call Pharmacy, LLC - August 02, 2017

This FDA Form 483 documents observations from an inspection conducted on July 25-26, 2017, concerning aseptic production procedures. The facility was observed producing Vancomycin (Lot# 753653A) in 14/1gm, 8/1.5gm, 10/1gm, 14/1.5gm, and 14/2gm doses, and Ceftriaxone (Lot# 720068M) in 27/2gm doses.

Two key violations related to personnel aseptic technique were noted: 1. **Exposed Hands:** On July 25, 2017, a sterile production technician was observed with bare hands exposed inside an ISO 5 laminar airflow hood while donning gloves, with another technician simultaneously engaged in sterile production nearby. 2. **Exposed Mouth and Contamination Risk:** On July 25, 2017, a sterile production technician in the ISO 7 sterile production room was observed holding the door to the Ante Room open, with her face mask pulled below her chin, while communicating with the pharmacist-in-charge. The technician subsequently returned to performing procedures in the sterile production room without sterilizing her gloved hands, indicating a breach in aseptic protocol and potential contamination of the sterile environment.