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

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

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