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The FDA cited Niagara Pharmaceuticals for distributing its private label OTC sterile eyewash preparations without an approved new drug
application and for violating cGMPs.
During FDA inspections, manufacturers can use certain techniques to avoid Form 483s, or to respond to FDA observations, Cathy Burgess said during an FDAnews audioconference March 27.
Manufacturers should approach their responses to Form 483s and FDA warning letters with a global perspective, experts said at
an FDAnews audioconference March 27.
The FDA told RyMed Technologies during a March meeting that the firm’s initial response to a Form 483 regarding alleged current good manufacturing practice violations satisfied the agency’s concerns, according to the firm.
Dermatology patients should avoid purchasing Roche’s Accutane or its generic equivalents over the internet, according to safety warnings on a new FDA website detailing the dangers of buying the drug online.
Fisher & Paykel Healthcare violated current good manufacturing practices by not documenting the assembly of its CosyCot radiant infant warmers and related accessories to guarantee that the devices meet product specifications, according to a recent FDA warning letter.
Takeda Pharmaceuticals has alerted healthcare providers about the increased risk of fractures related to Actos, Actosplus met and Duetact tablets, used to treat Type 2 diabetes mellitus.
Takeda’s television reminder ad for sleep agent Rozerem suggests that the product is indicated for use in children, making the it subject to the regulations of standard director-to-consumer advertising, according to a March 5 FDA warning letter.