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The FDA has issued Florida-based test manufacturer Empowered Diagnostics a warning letter for distributing COVID-19 test kits without marketing approval, clearance, or authorization.
Reviewing the deficiencies cited in FDA’s Form 483s inspection reports to devicemakers, just five areas account for almost 25 percent of all the observations by agency investigators each year. Read More
An FDA inspection of Apneicare’s medical device facility in Columbus, Ohio, turned up several repeat observations, including problems with handling complaints, completing corrective action reports and updating product labeling. Read More
To clear up any confusion about what the FDA considers delaying, denying, limiting, or refusing a drug or device inspection, the agency released a draft guidance on Thursday.
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
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