Tag:
FDA warning letter
Latest Headlines
Latest Headlines
Extremity Medical smacked with FDA warning letter
The FDA isn't happy with orthopedic device company Extremity Medical. Regulators smacked down the company for a number of alleged quality, problem-reporting and approval violations regarding the production of various screws and other implants.
FDA warns Synthes facility over complaint handling procedures
Synthes has not had the best couple of weeks. The company, which is facing legal action from families whose loved ones died after receiving a bone cement, is facing other problems--this time from the FDA over problems at its West Chester, PA, facility. That facility makes Click'X 3-D polyaxial heads, Click'X 3-D pedicle screws and N-Hance rods.
FDA calls out Biochem for IT no-nos
U.S. regulators have slapped Biochem Laboratories with a warning concerning several breaches. However, the one generating lots of buzz appears to be the contract testing lab's practice of letting...
Merit, PhotoMedex recipients of FDA warning letters
Two devicemakers, Merit Medical Systems ( $MMSI ) and PhotoMedex ($PHMD) have received FDA warning letters over what the agency has deemed misbranded and adulterated products made at their respective
FDA warns National Creative Enterprises on quality controls
The FDA has sent a warning letter--largely dealing with improper quality controls--to Burnsville, MN-based National Creative Enterprises, a manufacturer and distributor of battery packs and batteries
Teleflex resolves issues in FDA warning letter
Pennsylvania's Teleflex has successfully resolved all issues raised in an FDA warning letter received by its subsidiary, Arrow International, back in October 2007 . The letter identified the agency's
Anulex sees layoffs after FDA warning letter
Minnetonka, MN-based Anulex Techonologies has initiated a round of layoffs following a February warning letter from the FDA. In the warning letter, the FDA says it found "objectionable conditions"
Steris hit with FDA warning letter
Steris' struggles with the FDA continue. The agency cited the company for making improper marketing claims about several steam-sterilization devices. The Feb. 9 warning letter alleges the Mentor,
Smith & Nephew hit with FDA warning letter
Smith & Nephew has received an FDA warning letter over quality control concerns arising from a July inspection of the company's Tuttlingen, Germany facility. The devicemaker had sent a response
OsteoSymbionics gets warned by FDA
Craniofacial implant maker OsteoSymbionics has received an FDA warning letter for, among other things, failing maintain procedures to ensure certain design requirements were met. The inspection took
