FDA EIR - Steris Laboratories - April 12, 2017

STERIS Laboratories, located in Brooklyn Park, MN, underwent a routine comprehensive FDA inspection from April 6 to April 12, 2017. The inspection, conducted under Compliance Program 7341.002 and regulated by 21 CFR 1271.10(a) for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), focused on the firm's contract microbiological testing and sterilization dose audit services for human tissue samples. This included reviewing standard operating procedures, bioburden and sterility test results, equipment validation and maintenance, media preparation, deviation management, and complaint records.

Notably, the inspection concluded with a "No Action Indicated" classification, signifying a compliant outcome. The FDA investigator did not identify any inspectional observations, discussion items, or issues, and no FDA Form 483 was issued. This indicates that STERIS Laboratories' HCT/P-related operations were found to be in compliance with the relevant regulatory framework during the inspection period. No samples were collected, and no refusals were encountered. The firm had also undergone a name change from Biotest Laboratories, Inc. to STERIS Laboratories in February 2017, which was noted in the report.