We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The FDA hit Infusion Partners of Canfield, Ohio with a warning letter over shoddy manufacturing practices for sterile drugs including antibiotics. Read More
The FDA has cracked down once more on Indian pharma giant Aurobindo Pharma for manufacturing deficiencies at one of its facilities, slamming the company with yet another Form 483 over drugmaking violations and quality unit concerns. Read More
Adulterated products and contamination risks landed Columbia, Missouri compounder Apollo Care a warning letter from the FDA, in a follow up to a Form 483 report the agency issued after a March 2018 inspection. Read More
Sterile drugmaker Unither Manufacturing drew a Form 483 for quality deficiencies at its Rochester, New York facility, including investigations of out-of-specification results. Read More
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