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Home » Topics » Medical Devices » Inspections and Audits

Inspections and Audits
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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

FDA Observes Tennessee Devicemaker for Stability Studies

January 14, 2021
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

Kenlor Informed of Device Acceptance Procedure Findings

January 12, 2021
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

483 Roundup: Inspections Reveal Lapses at Five Device Facilities

January 7, 2021
FDA investigators observed problems with equipment calibration, validation studies and design verifications among other failings during inspections of five device manufacturing facilities. Read More

FDA Finds Lax Validation, Documentation at Ohio Facility

January 4, 2021
Numerous validation studies were found lacking during an FDA inspection of and numerous Synapse Biomedical’s Oberlin, Ohio facility. Read More
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