Unwrapped Cannulas Prompt Warning for Grams
The FDA issued Grams Medical a warning letter for sterilization problems related to its reusable cannula tips. Source: The GMP Letter
Renovis Surgical Warned Over Quality System Violations
Renovis Surgical Technologies received a strong warning from the FDA over its failure to conform to quality system regulations covering design verification, process validation, product development requirements and risk analysis.…
J&J Hit With Lawsuits Over Alleged Pelvic Mesh Injuries
Johnson & Johnson is facing lawsuits in two states that allege the company engaged in deceptive marketing claims for “new and revolutionary” surgical mesh used to treat women with pelvic…
WHO Creates Device Regulatory Blueprint for Developing Nations
The World Health Organization has published a model regulatory guidance for medical devices and IVDs intended to support developing nations that have yet to develop regulations covering medical devices. Source:…
Health Canada Updates Essure Labels
Canada is working with Bayer to update labels and increase monitoring of its Essure birth control implant. Source: The GMP Letter
Avoid Repeat CAPAs With Better Risk Management Tools
Having a risk tool to determine what situations require corrective and preventive actions is one strategy devicemakers can use to avoid repeat CAPAs. Source: The GMP Letter
FDA Warns German Diagnostics Maker Qiagen for TB Test Failures
The FDA issued a scathing warning letter to Germany-based Qiagen for numerous quality system failures related to its QuantiFeron TB test. Source: The GMP Letter
B. Braun to Pay $4 M to Resolve Criminal Liability Allegations
B. Braun Medical has agreed to resolve criminal liability allegations by paying $4.8 million in penalties and forfeiting an additional $4 million in restitution for selling contaminated pre-filled saline flush…
Theranos Voids Two Years’ Worth of Blood-Test Results
In the ongoing Theranos saga, the company has now rescinded test results from the past two years for its Edison blood-testing diagnostics. Source: The GMP Letter