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Home » Topics » Medical Devices » Inspections and Audits

Inspections and Audits
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FDA Warns Medtronic for Not Fully Investigating Infusion Pump Complaints

December 31, 2021
Medtronic has received a warning letter from the FDA for its Northridge, Calif.-based diabetes business. Read More

Chinese Devicemaker Warned for Mislabeling Nonsterile Devices

December 23, 2021
The FDA is blocking several devices manufactured by Global Medical Production of Jiaxing, China, from being imported into the U.S. due to serious quality violations. Read More

The Right Response to an FDA Inspectional Report May Avert a Warning Letter

November 19, 2021
A device manufacturer that undergoes an FDA inspection and gets a Form 483 with findings may avert a warning letter from the agency if it “really responds well,” said Jodi Scott, a partner at Hogan Lovells US, speaking Wednesday at the WCG and FDAnews-sponsored FDA Inspections vSummit. Read More

Acupressure Bracelet Maker Hit for Quality System Lapses

November 18, 2021
Failure to validate its products or to establish procedures that demonstrate its acupressure bracelets for nausea were manufactured according to specifications were among the 13 quality system lapses observed during a March 29 to April 1 FDA inspection of MumEase’s Charlotte, North Carolina facility. Read More

FDA Won’t Issue 483 Inspection Observations for Remote Assessments of Device Facilities

November 18, 2021
The FDA won’t be issuing Form 483 inspection reports following remote regulatory assessments (RRAs) of medical device facilities. Read More

FDA Got Creative with Inspections During Pandemic, Plans to Stay That Way

November 17, 2021
The pandemic forced the FDA to be far more innovative in its efforts to inspect device and drug manufacturing facilities, and the agency plans to incorporate these new modalities into its site surveillance process going forward. Read More

YFS Pharma Facility Hit for Failure to Investigate Complaints, Quality Deficiencies

November 17, 2021
Devicemaker YFS Pharma did not investigate or keep detailed records of complaints it received about its Lubricity dry mouth sprayer, FDA investigators observed during an inspection of the company’s Buffalo, N.Y., facility. Read More

Full Issue of Device Daily Bulletin Premium

October 20, 2021
View the entire issue. Read More

What’s the Problem with CAPAs?

October 20, 2021
Managing corrective and preventive action (CAPA) activities is a perennial problem for device manufacturers. Complaints, nonconformances, out-of-specification results all should generate a CAPA file, but the FDA continues to find fault with the way they are handled. Chances are, if you received a 483 at your last inspection, the words “corrective action” appeared prominently on the form. If they did, was your response detailed and specific enough to satisfy the FDA? Read More

Medical Device Reports, Corrective Actions Trip Up Ventilator Maker

October 11, 2021
Ventec Life Systems failed to send timely medical device reports to the FDA, and its procedures for corrective and preventive actions were not well established, an FDA investigator observed during an inspection of the company’s Bothell, Washington plant. Read More

FDA Cites Myerson for MDR Deficiencies, CAPA Lapses

September 13, 2021
Failure to file a medical device report within 30 days and to establish adequate procedures for corrective and preventive actions (CAPAs) were among the quality system deviations the FDA discovered during a March 16 to May 4 inspection of Myerson’s Chicago, Illinois facility. Read More

Acupressure Bracelet Maker Hit for Quality System Lapses

September 13, 2021
Failure to validate its products or to establish procedures that demonstrate its acupressure bracelets for nausea were manufactured according to specifications were among the 13 quality system lapses observed during a March 29 to April 1 FDA inspection of MumEase’s Charlotte, North Carolina facility. Read More
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