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A Wyoming manufacturer of dietary supplements claimed drug-like qualities for its products without obtaining the drug-marketing approvals that such claims require, the FDA said in a warning letter. Read More
A company that manufactures and repackages solutions used in kidney dialysis was cited by the FDA for selling products that failed quality tests and had not been cleared in reinspections before shipping, according to a warning letter from the agency. Read More
The FDA issued a warning letter to Euro-Diagnostica in Malmo, Sweden for its complaint and CAPA procedures as well as its quality audits, and said the company’s responses to observations from a January inspection were inadequate. Read More
CDER’s Office of Manufacturing Quality issued 45 warning letters through Sept. 1 of this year, not counting actions against compounders, according to Francis Godwin, a division director in OMQ. Read More
A New York City pharmacy that produces drugs as part of the multibillion-dollar Magellan Health healthcare management corporation was cited in an FDA warning letter for failure to maintain sterile processing procedures. Read More
A Chinese maker of pain-relief balms and ointments falsified results of tests on its products and deflected FDA inspectors seeking to examine its laboratory, the FDA said in a warning letter. Read More
The FDA cited a Dallas home infusion therapy pharmacy for failure to maintain sterile conditions for drugmaking after inspectors found dead insects in a cleanroom and in refrigerators used to store ingredients and finished products. Read More