FDA 483 - Instrumedical Technologies Inc - February 26, 2025
Discuss this record with AI
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.
Instrumedical Technologies Inc. in Warsaw, IN, was inspected from February 24-26, 2025, and received a Form 483 with two observations. The inspection revealed significant deficiencies in the firm's quality system, specifically regarding the control of nonconforming products and the maintenance of device master records. These issues indicate a lack of adequate procedures for rework, nonconformance evaluation, and established production process specifications for cleaning.
ID · 8e39df83-92a9-4235-97c3-a54fb8fdabf9