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…
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
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
Canada is working with Bayer to update labels and increase monitoring of its Essure birth control implant. Source: The GMP Letter
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:…
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…
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.…
The FDA issued Grams Medical a warning letter for sterilization problems related to its reusable cannula tips. Source: The GMP Letter
In response to a slew of warning letters regarding data integrity issues, the FDA is addressing questions on the matter that have come up in recent inspections. Source: Drug GMP…
The FDA has withdrawn the NDA for injectable fertility drug Luveris at the request of the manufacturer. Source: Drug Industry Daily