483
Titan Implants, IncFDA 483 - Titan Implants, Inc - February 20, 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.
Record Details
An FDA inspection of Titan Implants, Inc. in Bergenfield, NJ, a manufacturer of implants, revealed two significant quality system deficiencies. The firm failed to adequately document corrective and preventive actions, a repeat finding from a previous inspection. Additionally, the company did not properly establish requirements for suppliers and consultants, including review of purchasing documents and continuous monitoring of quality performance.
- Person
Open in Dashboard
ID · 1d64db09-d882-437f-992b-08755874cab2