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Sonablate’s manufacturing plant in Charlotte, N.C., landed a Form 483 after an FDA investigator found numerous issues with complaint reviews and reporting.
Smiths Medical has issued an urgent medical device correction letter to customers warning that its CADD (computerized ambulatory delivery device) infusion sets for use with CADD pumps could fail to deliver an infusion or could set off a false alarm. Read More
An FDA inspection of Prime Lab USA’s facility in Miami, Fla., landed the company a Form 483 for inadequately storing product, evaluating suppliers and handling customer complaints, among other lapses.
An FDA inspection of Polar Products’ device manufacturing plant in Stow, Ohio, found that the facility lacked proper design and other records and did not adequately evaluate incoming product or its suppliers.
Logistics such as making sure only the right personnel have access to documents and that those documents can be copied, printed or scanned may seem basic but they are critical to a successful FDA inspection, says David L. Chesney, principal of DL Chesney Consulting. Read More
A large part of the FDA inspection process is reviewing documents and those documents need to be accessible promptly on request, according to an FDA inspections expert speaking at the WCG FDAnews Annual FDA Inspections Summit in Washington, D.C., Nov. 16-18. Read More
Complete document archives with self-explanatory file names are the top two — out of the top 10 — ways to be prepared for an FDA inspection, advised an FDA inspections expert at the WCG FDAnews Annual Inspections Summit in Washington, D.C., Nov. 16-18. Read More
The integrity of manufacturers’ data is a major focus of FDA inspections and the agency’s investigators will go to great lengths to uncover problems, three former FDA inspection officials told attendees at the WCG FDAnews 17th Annual FDA Inspections Summit in Washington, D.C. last week. Read More
DeVilbiss Healthcare received a Form 483 from the FDA for inadequate complaint handling, design verification and lack of corrective and preventive action (CAPA) procedures, following an Aug. 1-17 inspection of its Somerset, Pa., facility. Read More
Eye movement tracking technology developer RightEye got a Form 483 for lapses in its design controls, product handling and complaint procedures, among other deficiencies observed during a June 28 to July 8 FDA inspection of its Bethesda, Md., facility. Read More
Mytrex, a manufacturer of personal emergency response systems, received a Form 483 from the FDA for lack of equipment testing and inadequate recordkeeping, among other lapses observed during an inspection of the company’s South Jordan, Utah, facility. Read More
Wintech Medipro, a manufacturer of surgical and medical face masks in Katy, Texas, has drawn a Form 483 for a host of observations, including inadequate complaint handling, medical device reporting and employee training. Read More