483
Medi-Globe s.r.o.Medi-Globe s.r.o. – FDA 483, May 24, 2018
Record Details
An FDA inspection of Med-Globe s.r.o., a medical device manufacturer in Hranice, Czech Republic, identified three observations related to deficiencies in their quality system. The firm was cited for inadequate procedures concerning corrective and preventive actions, quality audits, and calibration. These findings indicate a need for the firm to strengthen its procedural controls to ensure compliance and product quality.
View Company Profile
ID · b92bd626-23ed-47d5-863b-52ee8660fd2f
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.