Tag:
warning letter
Latest Headlines
Latest Headlines
Baxter warned for marketing infusion pump minus PMA
The FDA cited Baxter Healthcare for selling an infusion pump without premarket approval. As a result, the company's SIGMA Spectrum Infusion Pump with Master Drug Library is also misbranded, regulators allege in an April 1, 2013, warning letter addressed to Baxter CEO Robert Parkinson, Jr.
Abiomed gets out from under FDA's Impella warning letter
Abiomed has finally steered cleared the FDA's warning letter over how it marketed its Impella 2.5 heart pump, and now the company can focus on improving sales and getting back in investors' good graces.
FDA warns Bacterin over bone putty, wound drain product production
The FDA smacked Bacterin International with two separate warning letters, knocking the company for alleged quality and other violations over manufacturing of a bone putty product and two kinds of wound drains.
FDA confronts Mindray over patient monitor quality control
Mindray is in trouble with the FDA over manufacturing problems with the company's patient monitors and other medical equipment.
FDA warns Alere for cardiac DX quality shortfalls
The FDA is taking Alere ($ALR) to task for not acting fast enough to address manufacturing problems with its Triage cardiac diagnostic products.
UPDATED: FDA smacks EndoGastric Solutions with warning over study violations
U.S. regulators are taking EndoGastric Solutions to task over a number of alleged violations concerning an ongoing clinical study the company apparently placed on hold without ever telling regulators why. The company is testing treatments that address chronic acid reflux.
FDA cites bioMérieux for quality manufacturing violations in NC
The FDA cited French in vitro diagnostics player bioMérieux for a number of quality violations in a North Carolina manufacturing facility.
FDA slaps DPT with warning letter over sterility concerns
The FDA found sterility issues at DPT Laboratories' Center of Excellence for Sterile and Specialty Products, and the agency said DPT hasn't done enough to prevent future problems.
CSL nets closeout letter after FDA violations
After more than two years of manufacturing problems, CSL Biotherapies cleaned up its act, receiving a closeout letter from the FDA.
FDA wags finger at Sanofi for no-nos at vaccine plants
The FDA admonished Sanofi Pasteur on more than two dozen counts for "objectionable" conditions in two plants in Canada and France, according to a warning letter dated July 12 and made public July 24.
