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Home » Topics » Medical Devices » Inspections and Audits

Inspections and Audits
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ErgoMed Gets Form 483 for Lack of Supplier and Product Controls

February 3, 2023

San Antonio, Texas-based ErgoMed received a Form 483 after an FDA inspection found a lack of supplier and product controls as well as repeated quality lapses.

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RightEye Slapped with FDA Warning Letter for Lack of Premarket Approval

February 2, 2023

Bethesda, Md.-based RightEye, manufacturer of the RightEye Vision System, has received a warning letter from the FDA for marketing its device without a premarket approval application for new indications, failure to maintain written design control procedures and other serious lapses.

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Light Age Receives Form 483 for Missing Records, CAPA Actions

January 25, 2023

Light Age received a Form 483 for multiple deficiencies observed in an inspection of its Somerset, N.J., facility including the lack of a device master record and failing to launch corrective and preventive action (CAPA) procedures.

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Healthcare Workers Union Petitions FDA to Issue Recall of Fresenius Dialysis Machines

January 23, 2023

The SEIU-United Healthcare Workers West union in California has petitioned the FDA to issue corrective recalls for Fresenius 2008K2, 2008T, and 2008T BlueStar hemodialysis machines to protect patients from high ultrafiltration rates and assure accurate conductivity — concentration of dialysis fluid.

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Ceragroup Industries Gets Repeat Form 483 Observations for CAPA and Calibration Issues

January 19, 2023

Ceragroup Industries (CGI), a Florida manufacturer and distributer of dental porcelain products, recently received a Form 483 citing repeat problems with incomplete corrective and preventive action (CAPA) procedures and equipment lacking proper calibration. 

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Austco Lands Form 483 for Complaint Handling and Supplier Qualification

January 18, 2023

Failure to fully investigate complaints or to properly qualify suppliers landed devicemaker Austco Marketing and Service a Form 483 after an FDA inspection at its Irving, Texas, facility.

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iRhythm Technologies Rapped for Failing to Take Corrective Actions, Other Issues with Cardiac Monitoring System

January 13, 2023

An FDA inspection of an iRhythm Technologies facility in Irvine, Calif., resulted in a Form 483 to the firm for not establishing corrective and preventative actions, not submitting a medical device report (MDR), and other issues regarding the company’s cardiac monitoring system.

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FDA Issues Two Warning Letters to Olympus for MDR Reporting, Design Violations

January 12, 2023

The FDA has issued separate warning letters to Olympus Medical Systems and its subsidiary Aizu Olympus for failure to report malfunctions of endoscopes and inadequate validations.

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Cytophil Rapped for Lax Validations and Testing

January 4, 2023

An FDA inspection of East Troy, Wis., implantable medical device manufacturer Cytophil showed unvalidated processes and inadequate testing, among other lapses.

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Pedia Parents Rapped for Supplier Monitoring, Design Verifications

January 3, 2023

Buffalo, N.Y.-based Pedia Parents was handed a Form 483 after a July inspection found the company lacked adequate procedures for supplier monitoring, design verifications and medical device reports (MDR), among other lapses.

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RoyalVibe Health Gets Warning Letter for Unapproved Devices, Refusing Inspection

December 30, 2022

The FDA sent a Warning Letter to RoyalVibe Health for unapproved ultrasound technology devices the company has not removed from the market and for continuing to market the products online.

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FDA Issues Warning Letter for Unapproved COVID-19 Tests

December 29, 2022

The company previously recalled the tests, which the FDA designated as a Class 1 recall.

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