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Failure to control product that did not conform to specifications, and failure to validate software landed contract manufacturer Viant AS&O Holdings in hot water with the FDA following an Oct. 20-23, 2020 inspection at the firm’s Orchard Park, New York facility. Read More
Complaints involving the possible failure of a device to meet any of its specifications weren’t evaluated and investigated by Medtronic’s Heart Valves Division, according to a Form 483 the firm received following an Oct. 13-26, 2020 inspection of Medtronic’s Santa Ana, California facility. Read More
Numerous repeat observations including failure to establish corrective and protective action (CAPA) and design control procedures were observed during an Oct. 5-7, 2020 FDA inspection of CPAPNEA Medical Supply’s Phoenix, Arizona facility. Read More
Complaints involving the possible failure of a device to meet any of its specifications weren’t evaluated and investigated by Medtronic’s Heart Valves Division, according to a Form 483 the firm received following an Oct. 13-26, 2020 inspection of Medtronic’s Santa Ana, California facility. Read More
Numerous repeat observations including failure to establish corrective and protective action (CAPA) and design control procedures were observed during an Oct. 5-7, 2020 FDA inspection of CPAPNEA Medical Supply’s Phoenix, Arizona facility. Read More
Failure to control product that did not conform to specifications, and failure to validate software landed contract manufacturer Viant AS&O Holdings in hot water with the FDA following an Oct. 20-23, 2020 inspection at the firm’s Orchard Park, New York facility. Read More
Failure to establish procedures to control product that did not conform to specifications, as well as procedures to ensure equipment is routinely checked, were among the deficiencies uncovered during an FDA inspection of contract manufacturer Apical Instruments of Redwood City, California. Read More
Among other observations, the FDA investigator found a lack of evidence demonstrating if a sterile barrier is maintained in packaging when the product is stored under worst-case conditions. Read More
Corrective and preventive actions were also found to be inadequate because they didn’t ensure that the root cause of nonconformances was identified during investigation, the Form 483 said. Read More
The FDA investigator noted that the device history record showed several instances in which a urine-dipstick control failed quality testing and acceptance testing was not documented but the product was packaged and released. Read More
FDA investigators observed problems with equipment calibration, validation studies and design verifications among other failings during inspections of five device manufacturing facilities. Read More
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