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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
Texas Medical Technology received a Form 483 from the FDA for a variety of lapses observed during a Feb. 16 to March 3 inspection at its Houston facility, ranging from inadequate device records to ineffective medical device reporting (MDR) procedures. Read More
C&A Tool’s Auburn, Ind. device manufacturing facility received a Form 483 from the FDA for good manufacturing practice issues and other deficiencies observed during a Feb. 28 to March 3 inspection. Read More
Seno Medical Instruments received a Form 483 after the FDA inspected its San Antonio, Texas, facility last February and March, listing inadequate design control procedures and other lapses. Read More