FDA 483 - Nubratori, Inc - September 26, 2019

This FDA Form 483 was issued to Nubratori, Inc dba Nubratori Rx, an outsourcing facility located at 381 Van Ness Ave Ste 1507, Torrance, CA 90501-7220. The inspection was conducted from August 26, 2019, to September 26, 2019. Dr. Gulshakar Khwaja, RPh, MS, PharmD, Chief Operating Officer, was the individual to whom the report was issued.

The inspection revealed three observations:

1. **Procedures to prevent microbiological contamination of sterile drug products are not established.** * A smoke study video from June 28, 2019, for in situ air pattern analysis, was not conducted under dynamic conditions simulating routine production, such as manipulation and injection of drug product into multiple sealed vials. This raises concerns about the suitability of critical processing areas for aseptic manufacturing. * On August 28, 2019, a compounding technician allowed vials and tubing lines to obstruct "first air" during the vial filling of Lidocaine HCl w/Bupivacaine HCl Injection USP, Lot No. C08281901. * On September 24, 2019, a compounding technician allowed a gloved hand and vial to obstruct "first air" during