FDA 483 - Isorx Corp - September 18, 2019

On September 18, 2019, the FDA issued a Form 483 to Isorx, Corp., a producer of sterile and non-sterile drugs located at 845 Marina Bay Parkway, Suite 9, Richmond, CA 94804, following an inspection conducted from September 9-18, 2019. The report was issued to Michael J. Whyte, Owner.

The inspection revealed four observations:

1. **Materials or supplies were not disinfected prior to entering aseptic processing areas.** On September 11, 2019, a pre-sterilized/depyrogenated syringe was removed from the ISO 5 laminar flow hood and cleanroom, exposed to unclassified air, and then returned to the ISO 5 hood for the production of I-123 Metaiodobenzylguanidine (MIBG) USP, Rx (b)(4), lot 119141 MIBG, a sterile drug product.

2. **Disinfecting agents and cleaning wipes used in the ISO 5 classified aseptic processing areas were not sterile.** On September 11, 2019, non-sterile wipes were used for pre-operational cleaning of the ISO 5 laminar flow hoods, which were used to produce I-123 Metaiodobenzylguanidine (MIBG) Rx (b)(4), lot