483
Integrity Medical Devices Inc.FDA 483 - Integrity Medical Devices Inc. - January 08, 2024
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.
Record Details
An FDA inspection of Integrity Medical Devices Inc. in Hammonton, NJ, from October 2023 to January 2024, revealed significant deficiencies in the firm's process validation and monitoring. The company failed to adequately establish monitoring for its validated package sealing process for sterile products and did not fully validate its bottle tamper seal process, raising concerns about product quality and integrity.
- Person
Open in Dashboard
ID · 08728a8e-ac75-4b2d-8986-b2edecfed97d