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.
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.
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.
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 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.
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.
Mindray is in trouble with the FDA over manufacturing problems with the company's patient monitors and other medical equipment.
The FDA is taking Alere ($ALR) to task for not acting fast enough to address manufacturing problems with its Triage cardiac diagnostic products.
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.
The FDA cited French in vitro diagnostics player bioMérieux for a number of quality violations in a North Carolina manufacturing facility.