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The FDA has cited Actavis Totowa for deficiencies with its quality control unit, including a failure to investigate out-of-specification test results and to record all data.
Bell-More Laboratories failed to properly maintain the building where it manufactures its drugs, allowing the products to become contaminated, an FDA warning letter said.
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.
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.