FDA 483 - Solaris Pharmacy, Inc. - February 26, 2020

Solaris Pharmacy, Inc. in Decatur, TX, was inspected by the FDA from February 19-26, 2020, and received two observations. The inspection revealed issues with unsuitable cleaning agents for non-sterile drug production and the use of non-pharmaceutical grade components in compounded drugs. These findings indicate significant concerns regarding the quality and safety of the firm's non-sterile drug products.