The FDA slapped Smith & Nephew with a warning letter for quality-control violations at its Andover, MA, facility related to problems with some of the company's mechanical morcellators for removal of intrauterine tissue. The company has placed a hold on shipments of its Truclear Ultra Reciprocating Morcellator 4.0 while it further investigates customer complaints.
The FDA has issued a stern warning to infection control specialist Cenorin, advising the company to correct violations such as failing to notify the FDA of a correction sent to users of its medical device disinfection system.
The FDA issued Paris-based AB Science a warning letter regarding its Kinavet-CA1 canine drug, intended for mast cell tumors in dogs, for allegedly boasting its off-label uses without approval.
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.