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Greiner Bio-One neglected to finish validation testing for the qualification of a new supplier it used in the manufacturing of its Vacuette brand blood collection tubes, the agency said. Read More
The agency received several responses, but they were deemed inadequate because they didn’t address process changes between the two heating fixtures. Read More
Missing design control procedures for Nexalin Technology’s transcranial electrotherapy stimulator landed the firm a Form 483 following an inspection of its Houston, Texas facility. Read More
Kesair Technologies lacked proper procedures to ensure that its air sanitation devices were designed in accordance with the FDA’s quality system regulation, the agency said, following an inspection of the firm’s Kennesaw, Georgia facility. Read More
Greiner Bio-One North America failed to complete validation testing and didn’t evaluate the effect of a manufacturing change, among other quality system failures, the FDA said in an April 16 warning letter. Read More
Luminex started using heater fixtures produced by a new component manufacturer in 2019; however, the change was implemented without an approved validation plan, according to a June 26 warning letter. Read More
FDA Commissioner Stephen Hahn said that the agency will resume domestic inspections this month using a new risk assessment system developed in response to the pandemic. Read More
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