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Home » Topics » Medical Devices » Inspections and Audits

Inspections and Audits
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FDA Slaps CellEra for Inadequate Complaint, CAPA and MDR Procedures

August 29, 2022
CellEra has received a Form 483 for not having proper procedures for handling complaints and corrective actions and for other deficiencies observed during an April 11-14 inspection of the company’s Monroe, Ohio, facility. Read More

FDA Hits Aggredyne with Form 483 Over Design Changes

August 26, 2022
Aggredyne drew a Form 483 from the FDA for deficient design change validations and other lapses following an inspection of its Houston, Texas, manufacturing facility from March 29 to April 14. Read More

Nonconforming Product Issues Get Allied Healthcare Products a Form 483

August 25, 2022
The FDA has handed Allied Healthcare Products a Form 483 citing improper handling and documentation of product nonconformances following an inspection of the company’s facility in St. Louis, Mo., in April and May. Read More

FDA Raps Devon Orthopaedic Implants for Improper Complaint Handling, Event Reporting

August 22, 2022
Devon Orthopaedic Implants received a Form 483 from the FDA following a May inspection of its facility in King of Prussia, Pa., for failing to fully investigate complaints or report possible medical device issues. Read More

Revolutionary Science Hit for Inadequate Device History Records, Documentation

August 16, 2022
The FDA issued Revolutionary Science a Form 483 for documentation issues involving design changes, nonconforming product and in-process testing observed during an inspection of its Shafer, Minn., facility in April. Read More

Elite-Medical Hit With Form 483 for Product Control, Supplier Issues

August 15, 2022
The FDA handed Elite-Medical a Form 483 for problems with control of nonconforming products and a supplier issue observed during an inspection of its Florence, Ala., facility in April. Read More

Med Pen Concepts Lacking Basic Product Documentation for Plasma Pen, Form 483 Says

August 12, 2022
An FDA inspection of Med Pen Concepts’ facility in Woburn, Mass., found the company lacked documentation of corrective and preventive action (CAPA) procedures, device history records, risk assessments and audit reviews for its plasma pen devices. Read More

QuadM Technologies Receives Form 483 for Documentation Lapses

July 25, 2022
QuadM Technologies received a Form 483 from the FDA after an inspection of its Hamilton, N.J., facility in April that highlighted a variety of documentation issues. Read More

Health Care Technology Gets 483 for Lack of Documentation, Quality Procedures

July 22, 2022
Failure to ensure that its medical devices met regulatory and other requirements landed Health Care Technology (HCT) a Form 483 from the FDA following an inspection at its Ashland, Mass. facility in April. Read More

FDA Hands Phoenix Diagnostics Form 483 for Inadequate CAPA and Training Procedures

July 20, 2022
Inadequate corrective and preventive action (CAPA) and training procedures landed Phoenix Diagnostics with a Form 483 after the FDA inspected the company’s Natick, Mass., facility in March. Read More

Craftmatic Industries Receives Form 483 for Product Noncomformance, Reporting Issues

July 19, 2022
Craftmatic Industries received a Form 483 for repeated problems with product quality and complaint-reporting issues observed in an FDA inspection of its Pompano Beach, Fla., facility earlier this year. Read More

Precision Nuclear of Virginia Draws FDA Form 483 Over Quality Issues

July 18, 2022
Precision Nuclear of Virginia landed a Form 483 following a March 22 to 25 inspection of its Roanoke, Va., facility where FDA officials observed multiple quality lapses. Read More
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