FDA 483 - Sterigenics US, LLC - May 04, 2023

An FDA inspection of Sterigenics US, LLC, a contract gamma sterilizer in West Memphis, AR, revealed significant deficiencies in their quality system. The firm failed to adequately establish corrective and preventive actions for spectrophotometer test failures and did not evaluate the impact of out-of-specification test equipment on device quality. Additionally, Sterigenics lacked written Medical Device Reporting (MDR) procedures.