FDA EIR - Sterigenics U.S. LLC - April 27, 2018

An FDA inspection of Sterigenics U.S. LLC in Mulberry, FL, conducted from April 24-27, 2018, identified significant deficiencies in their contract gamma sterilization processes for medical devices. The inspection was carried out under Compliance Programs for Human Cells, Tissues, and Cellular and Tissue Based Products (HCT/Ps) and Medical Device Manufacturers, referencing the Federal FD&C Act and Public Health Service Act. The main violations, documented on an FDA Form 483, concerned process validation (21 CFR 820.75(a)) and acceptance activities (21 CFR 820.80(a)). Firstly, the company processed medical devices whose weights deviated significantly (up to 30%) from validated load specifications. This raised concerns that the gamma irradiation process might not consistently achieve the intended sterilization dose, especially since their own studies indicated dose distribution is affected by product density variations within a load. The company's method of placing dosimeters was questioned for its accuracy in these varied conditions. Secondly, Sterigenics lacked adequate written procedures for verifying incoming medical device packages met required specifications, such as dimensions, weight, and density, before sterilization. Although personnel performed these checks informally, the absence of documented procedures and records meant critical quality assurance steps were not formally controlled or verified. In response, Sterigenics committed to conducting additional qualification studies to address product density variations and to ensure customers comply with package specifications or require new dose mapping. They also promised to establish formal written procedures for acceptance activities and record keeping.