483
Starkey Laboratories IncStarkey Laboratories Inc – FDA 483, Nov 13, 2018
Record Details
An FDA inspection of Starkey Labs Inc in Eden Prairie, MN, conducted from November 7-13, 2018, identified a significant deficiency related to document control. The firm failed to adequately establish and implement procedures, specifically lacking documented approvals for critical manufacturing procedures and software validation plans for RTA machines. This indicates a moderate severity issue concerning the firm's quality system.
View Company Profile
ID · 4a3bb024-14ff-457a-8581-fe581e678857
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.