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Home » Topics » Medical Devices » Inspections and Audits

Inspections and Audits
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UK’s MHRA Resumes In-Person Inspections

April 1, 2021
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

FDA Warns Wound Dressing Manufacturer Over Quality Issues

April 1, 2021
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

UK’s MHRA to Resume In-Person Inspections Next Week

March 29, 2021
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

Notified Body Told to Pull Guidance on Remote Audits

March 23, 2021
“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

New York Contract Manufacturer Hit for Repeat Observations

February 4, 2021
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

Medtronic Hit for Failing to Properly Investigate Reports of Device Failure

February 4, 2021
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

Repeat Observations Dog Arizona Mask Maker

February 4, 2021
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

Medtronic Hit for Failing to Properly Investigate Reports of Device Failure

February 1, 2021
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

Repeat Observations Dog Arizona EPAP Maker

February 1, 2021
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

New York Contract Manufacturer Viant Hit for Repeat QS Observations

February 1, 2021
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

Contract Manufacturer Fails to Document Nonconforming Product

January 18, 2021
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

FDA Notes Validation Study Observations During Inspection of Ohio Facility

January 14, 2021
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
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