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Home » Topics » Medical Devices » Inspections and Audits

Inspections and Audits
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FDA Issues Warning Letter for Unapproved COVID-19 Tests

December 29, 2022

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.

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CAPA Procedures Top the List of Quality Compliance Traps

December 20, 2022
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

FDA Raps Apneicare for Recurring Inspection Observations

December 20, 2022
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

FDA Details ‘Delaying, Denying, Limiting or Refusing’ Drug or Device Inspections

December 19, 2022

Devices are considered “adulterated” if the manufacturer refuses an FDA inspection.

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FDA Details ‘Delaying, Denying, Limiting or Refusing’ Drug or Device Inspections

December 16, 2022

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what the FDA considers delaying, denying, limiting, or refusing a drug or device inspection, the agency released a draft guidance on Thursday. 

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Sonablate Draws Form 483 for Not Investigating and Reporting Complaints

December 14, 2022

Sonablate’s manufacturing plant in Charlotte, N.C., landed a Form 483 after an FDA investigator found numerous issues with complaint reviews and reporting.

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Smiths Medical Warns of Potential Issues With Infusion Sets

December 13, 2022
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

Prime Lab USA Handed Form 483 for Temperature Control, Complaint Handling Issues

December 12, 2022

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.

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Polar Products Gets Form 483 for Lax Records and Product Controls

December 8, 2022

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.

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FDA Inspection Readiness: Logistics and Securing Document Access

December 7, 2022
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

FDA Inspection Readiness: Be Able to Find Your Documents Quickly

November 30, 2022
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 Archives with Clear File Names Key to Successful FDA Inspection

November 22, 2022
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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