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China’s Copious International fell short on submitting medical device reports and tracking complaints, as well as validation procedures, a Feb. 5 to Feb. 8 inspection of the firm’s Guang Dong, China facility revealed. Read More
The FDA issued a warning letter to US Vascular for failing to correct deficiencies in its complaint reviews and to fix problems with medical device reporting, among other violations. Read More
The firm’s risk analysis listed the hazards associated with excessive time as “safe,” the FDA said, noting that the firm had not adequately assessed and mitigated the potential risk. Read More
In a warning letter to Becton Dickinson Medical System, the FDA said the devicemaker must further document its corrections to problems with environmental conditions and safeguards against contamination. Read More
Although deviations were reported, all possible root causes were not identified to ensure that corrective actions would prevent reoccurrence, the FDA said. Read More
Failure to establish a design history file or to put procedures in place to control device history records, in addition to failure to conduct quality reviews, landed devicemaker LSVT Global a 10-item Form 483 following a July 16 to July 17 inspection of is plant in Tucson, Arizona. Read More
Procedures for submitting medical device reports to the FDA, as well as inadequate CAPA procedures were among the numerous quality system failures uncovered during a Jan. 29 to Feb. 1 inspection of Beijing Polycon Medical Engineering’s plant in Beijing. Read More