Tag:

warning letter

Latest Headlines

Latest Headlines

23andMe digs in as FDA demands tests come off the market

Now that the FDA has fired off a strongly worded rebuke of its Personal Genome Service, 23andMe is standing by the accuracy of its un-approved test, promising to work with regulators but giving no indication that it'll stop selling its sole product.

FDA slams Wockhardt with warning letter on troubled plant

Wockhardt said over the weekend that the FDA had issued a warning letter related to shortfalls at its facility in Waluj, India. Drugs made there had already barred from entry into the U.S., U.K. and EU.

FDA warning letter cites Baxter for mold at plant, hair in infusion products

The FDA has sent Baxter International a warning letter laying out problems it found during inspections at a plant in North Carolina as well as at a plant in Jayuya, Puerto Rico.

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.