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Topspins, a specification developer and own-label distributor of IV tubing sets, was warned by the U.S. FDA after making design changes without appropriate validation. Read More
Integra LifeSciences has resolved the second of three warning letters it received over 15 months, announcing a closeout letter from the FDA for its Anasco, Puerto Rico, facility. Read More
Praxair, a specification developer for gas flow regulators, received a warning letter from the FDA for MDR failures following fires and other quality issues. Read More
Integra LifeSciences has resolved the second of three warning letters it received over 15 months, announcing a closeout letter from the U.S. Food and Drug Administration for its Anasco, Puerto Rico, facility. Read More
Respironics California, a Philips subsidiary, received an FDA warning letter for medical device reporting failures, including one related to a life-sustaining/life-supporting device. Read More
MedOne Surgical, a Sarasota, Fla., devicemaker, received an FDA Form 483 for failures related to complaint records, in-process acceptance and other procedures. Read More