483
SMITHS MEDICAL ASD, INC.SMITHS MEDICAL ASD, INC. – FDA 483, Apr 11, 2018
Record Details
An FDA inspection of SMITHS MEDICAL ASD, INC. in Oakdale, MN, revealed a lack of an established quality plan and inadequate control over contract suppliers. Specifically, the firm failed to ensure that critical components for their Medfusion infusion pumps met specifications, leading to out-of-specification parts contributing to field failures. This indicates significant deficiencies in their quality management system.
- Person
View Company Profile
ID · dcaa64a6-9c1f-4b5f-bf75-f95666878031
Other documents for SMITHS MEDICAL ASD, INC.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.