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The FDA ordered 20 companies to stop manufacturing unapproved drug products containing ergotamine tartrate as part of the agency’s safety efforts to keep unapproved drugs off the market.
Encore Medical’s reworking of its Speedblock surgical instruments caused the premature failure and splitting in half of the devices during surgery, prompting a recall of the product, the FDA said in a recent warning letter.
The FDA warned DreamWest Innovations for failing to establish adequate design and testing files for its rapid intubation kits, making the products adulterated.
The FDA has warned Applied Water Engineering for manufacturing its dialysis devices without conducting quality audits or performing necessary complaint response procedures.