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The China Food and Drug Administration has issued 90 industry standards — 14 mandatory and 76 recommended — covering implants for surgery, medical electrical equipment, in vitro diagnostic reagents and dentistry. Read More
A contact lens manufacturer that failed to respond to a Form 483 in February following an FDA inspection now must respond to a warning letter. Read More
The new tests will ascertain whether low-dose computed tomography is needed, as well as determine the malignancy status of nodules from LDCT screening. Read More
A Jackson, Miss., devicemaker received a 16-count Form 483 from the FDA’s Detroit district office after an inspection found major problems with the company’s risk analysis, testing procedures and employee training. Some of the observations were repeated from a 2012 inspection. Read More
Inspectors from the FDA’s Florida district office found a pattern of missing or faulty records of supplier audits at a Clearwater, Fla.-based Soft Computer Consultants, leading to an eight-observation Form 483 for the company. The company also received a Warning Letter from the FDA. Read More