The FDA hit Murrieta, Calif., compounder Innovative Intrathecal Solutions with a warning letter over serious violations that caused its drug products to be adulterated.
The agency inspected the company, doing business as Innovative Compounding Pharmacy, from Oct. 2 to Dec. 18, 2017. The investigators observed a facility operator using a non-sterile wipe to clean the interior surfaces of an ISO-5 work area — as well as a product vial’s rubber stopper — while a sterile drug product was being made.
The firm’s ISO 7 cleanroom also contained items that were complicated to clean, such as a computer keyboard, a hand-held calculator and many pieces of particle-generating paper. Additionally, the firm did not test the integrity of a filter after sterile filtration of drug products, instead relying on an operator’s assessment to evaluate its integrity during the filtration process.