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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
Viramed Biotech, a German manufacturer of in vitro diagnostics, received a one-observation Form 483 related to an issue with its quality control procedure. Read More
The FDA has warned a Mississippi compounder for not disinfecting its clean room equipment and for other serious manufacturing violations, capping a busy year for the agency’s compounding pharmacy enforcement. Read More