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The FDA is advising Newport Medical Instruments to include corrective actions instituted to resolve continuing complaints regarding the battery life for its HT-50 Homecare ventilators in the firm’s response to a recent warning letter.
Abbott Laboratories is retaining an outside consultant to audit the manufacturing and quality systems (QSs) at its diagnostics division following a request in a March 13 FDA warning letter, Abbott told D&DL.
A clinical investigator failed to supervise a drug clinical trial she was conducting, delegating her responsibilities to a site management organization whose CEO committed multiple violations, according to an FDA warning letter.
Wyeth will respond this month to Form 483 observations from an FDA reinspection of the company’s Guayama, Puerto Rico, manufacturing facility, the firm announced.
The FDA told RyMed Technologies during a meeting that the firm’s initial response to a Form 483 regarding alleged cGMP violations satisfied the agency’s concerns, according to the firm.
Fisher & Paykel Healthcare violated cGMPs by not documenting the assembly of its CosyCot radiant infant warmers and related accessories to guarantee that the devices meet product specifications, according to an FDA warning letter.
Medical Concepts Development (MCD) failed to take corrective action to address bioburden levels exceeding action/alert thresholds on its surgical drapes, according to a recent FDA warning letter.
Abbott Laboratories is retaining an outside consultant to audit its manufacturing and quality assurance systems at its diagnostics division following a request in a March 13 FDA warning letter, Abbott told GMP.
Boston Scientific anticipates that it will be ready for the FDA to audit its drug-eluting stent manufacturing operations and compliance systems by mid-2007, according to Chief Operating Officer Paul LaViolette.
Manufacturers should approach their responses to Form 483s and FDA warning letters with a global perspective, experts said at a recent FDAnews audioconference.