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Germany’s Dannoritzer Medizintechnik received a six-item Form 483 following a Feb. 5 to Feb. 8 inspection of its Baden-Wuttemberg facility for inadequate validation and process control procedures for its surgical equipment. Read More
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