We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
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
Devicemakers should never be concerned that an FDA inspector will cite them for opening “too many” corrective and preventative actions, a CDRH official says. 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
Natus Manufacturing Limited, an Irish devicemaker, received an FDA Form 483 for slips related to acceptance activities and contamination-prevention 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
During an FDA inspection, an employee of Precision Needle Manufacturing placed a bin of needle protectors on the ground and then later stacked the same bin on top of another container with exposed needle protectors, according to a Form 483. Read More
CooperVision’s Puerto Rico facility has received an FDA warning letter for inadequate investigations into nonconformities and other GMP issues. While the company will need to improve staff training, the letter should not hurt operations or approvals, an analyst says. 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 device company HeartWare International said Wednesday that it received an FDA warning letter related to the company’s Miami Lakes, Fla., manufacturing facility. Read More