We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) resumed in-person inspections on March 29 but it is adopting a hybrid approach that allows for both remote and on-site elements. Read More
The FDA issued a warning letter to Tarmac Products, a Miami Gardens, Florida manufacturer of surgical wound dressings for issues with its medical device quality system. Read More
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) plans to resume in-person inspections starting March 29 but it will adopt a hybrid approach that allows for both remote and on-site elements. Read More
“At this time, Team-NB is unfortunately unable to finalize and publish its aligned position on the uniform implementation of such remote audits by notified bodies,” the notified body said. 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
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
RSS
