The FDA cited a Vital Laboratories facility in Gujarat, India over failure to investigate out of specification results, conditions for material storage, and employee training. Read More
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 fro... 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
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