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The U.S., Canada, Australia and Brazil were supposed to begin shared audits this month under the International Medical Device Regulators Forum’s medical device single audit program. Read More
The Utopia Group, a specification developer for an umbilical cord clamp and cutter, received an FDA warning letter for making product changes without following regulations and for lacking a host of procedures. Read More
Enhancement Medical received a warning letter for failing to document supplier evaluations related to production of the Expression intranasal splint. Read More
CoHiTech, a Barcelona, Spain, manufacturer of tampons and menstrual pads, received an FDA warning letter for in-process testing procedures and other quality issues. Read More
Coronary devicemaker HeartWare International has received an FDA warning letter related to the company’s Miami Lakes, Fla., manufacturing facility. Read More
IBSA Farmaceutici did not open a corrective action, as required, for a trend in adverse events involving pain and/or swelling in the knee following injection of Sinovial or other sodium hyaluronate devices, according to a Form 483. Read More