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Failure to establish procedures for quality audits and management reviews landed C-PAP maker Somnowell a May 12 warning letter for numerous quality system violations. Read More
Failure to set requirements to evaluate suppliers landed Berwickshire Electronic Manufacturing, a UK contract manufacturer, an FDA warning letter. Read More
Not finding the root causes of problems or documenting complaint evaluations landed General Devices, maker of mobile telemedicine systems, a warning letter from the FDA. Read More
TYRX, a Medtronic subsidiary and developer of absorbable antibacterial envelopes, received an FDA warning letter for issues with CAPA investigations and change controls. Read More
If the FDA conducts a benefit-risk assessment and finds the device has a high benefit to patients and the compliance issue causes little risk, it may decide to work with a company informally, rather than taking an official enforcement action. Read More
Explosion fears have prompted the FDA to warn facilities and consumers not to use one of OxySure Therapeutic’s portable emergency oxygen systems. Read More
The FDA has slammed Advanced Vision Science for potentially distributing intraocular lenses in the U.S. that were rejected for the Japanese market. Read More