FDA EIR - St. Jude Medical - March 20, 2019

An FDA compliance follow-up inspection was conducted at St. Jude Medical's Minnetonka, MN facility on March 20, 2019. The company, now part of Abbott Laboratories, Inc., manufactures Class II and III medical devices, including NeuroTherm cannula/needle assemblies at this location. This inspection served as a follow-up to a Warning Letter issued in 2012 to the original NeuroTherm owner/operator, and was conducted under Compliance Program 7382.845 and the QSIT handbook, focusing on medical device manufacturer regulations, including 21 CFR 820.30(j) for Design History Files and 21 CFR 820.70(a) for Production and Process Controls.

During this inspection, the FDA found no objectionable conditions and issued no new FDA Form 483 observations at the Minnetonka location. The report indicated successful resolution of previous deficiencies concerning the Design History File for cannulas, with no concerns noted upon review. Production and process controls for cannulas were also observed and reviewed, demonstrating conformity to specifications without issue. An internal Corrective and Preventive Action (CAPA 17077) related to past cannula length specifications from a supplier was noted, which resulted in a supplier change and increased verification. Verification of effectiveness for this CAPA was pending. The Minnetonka site successfully addressed the Warning Letter items under review.