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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
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
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
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
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 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
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
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 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 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
Devicemaker CooperSurgical, a division of CooperCompanies, was slapped with a five-observation Form 483 for manufacturing problems primarily focused on its intrauterine device (IUD) Paragard T380A copper contraceptive. Read More