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The FDA slammed Altamonte Springs, Florida stem cell product manufacturer Cord for Life for committing GMP violations and failing to meet regulations for its products. Read More
The FDA hit a Baxter Healthcare sterile drug facility in Jayuya, Puerto Rico with a lengthy Form 483 listing numerous violations the agency observed in a Dec. 3-21, 2018 inspection. Read More
The FDA issued warnings to four homeopathic drug manufacturers for quality violations—including King Bio of Asheville, North Carolina, which recalled hundreds of products last year. Read More
The FDA hammered five drug manufacturers — one Indian and four American — for varying issues at their drug making facilities, sending the companies Form 483s for their violations. Read More
Five American drugmakers were hit with warning letters after the FDA discovered an assortment of issues at their facilities, including contamination risks, missing procedures and issues with cleaning. Read More
The FDA hit OTC drug manufacturer Tomco-Harwel Industries with an extensive Form 483 for numerous violations at its Tulsa, Oklahoma facility. Read More
The FDA issued a warning letter to Thibiant International for producing defective OTC drugs at its Newbury Park, California manufacturing facility. Read More
The FDA cited the University of Texas Southwestern Medical Center for significant violations at its positron emission tomography (PET) drug manufacturing facility in Dallas. Read More
The FDA issued a warning letter to United Exchange Corp. for serious quality violations, including using products from “multiple sub-standard contract manufacturers” at its Cypress and Rialto drug manufacturing plants. Read More
In the FDA’s latest effort to crack down on illicit online distributors, the agency issued a warning letter to Nutra Pharma in Coral Springs, Florida for selling unapproved pain relief drugs. Read More
Indian drugmaker Jubilant Generics drew an FDA warning letter over repeat quality violations and inadequate complaint investigations at a facility in the northern state of Uttarakhand. Read More