FDA EIR - Nelson Laboratories, LLC - March 30, 2018

A routine cGMP surveillance inspection of Nelson Laboratories, LLC, a contract testing laboratory in Salt Lake City, UT, was conducted from March 27-30, 2018. This inspection, carried out under compliance program 7356.002 for Drug Process Inspections, focused on chemical and microbiological analyses for drugs, medical devices, and tissues. Notably, no FDA Form 483, Inspectional Observations, was issued at the conclusion of this inspection.

However, two key issues were discussed with management. First, aseptic techniques during bioburden testing were identified as deficient, with a laboratory technician observed handling samples after touching an external keyboard without proper glove sanitization or change. Second, the firm could not definitively assure that its distributed Process Challenge Devices (PCDs) were not intended for use in healthcare facilities. The FDA clarified that if these PCDs are deemed medical devices, failures (such as detached caps from a previous Quality Event QE13532) could necessitate a medical device recall and FDA notification.

Nelson Laboratories' management acknowledged these discussion points and committed to correcting the aseptic technique deficiencies and revising PCD Certificates of Analysis and its website to clearly state that their PCDs are not intended for the healthcare industry. The FDA indicated that the firm's PCD distribution operations would be further evaluated during a subsequent medical device inspection.