FDA 483 - Option Care - August 02, 2017

This FDA Form 483 was issued to Option Care, a producer of sterile drugs, located at 9030 Kirby Drive, Houston, TX 77054. The inspection was conducted from July 25-28, 2017, and the 483 was issued on August 2, 2017, to Amy Groves, RN, MSN, Director of Operations.

The sole observation noted during the inspection was that disinfecting agents used in the ISO 5 area were not sterile. Specifically, the firm was observed utilizing non-sterile disinfectants, including "Spor-Klenz," in the ISO 5 area. This indicates a potential quality system and manufacturing issue related to maintaining a sterile environment for drug production. The document does not specify any regulatory citations or further business/operational implications beyond this single observation.