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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
Spectral data was also not saved automatically by the spectroscopy instrument, and the firm’s quality control unit did not review the audit trails of the generated analytical data used to clear incoming raw materials. Read More
The FDA issued a warning to Pfizer subsidiary Hospira Healthcare India for contamination risks, out-of-specification batches and other violations observed at its Chennai, Tamil Nadu facility. Read More
The FDA slapped drug manufacturer Gordon Laboratories with an eight-observation Form 483, calling the company out for testing and other violations at its Carson, California facility. Read More
Teva subsidiary Actavis Pharmaceuticals drew a warning letter from the FDA for laser-drilled tablet manufacturing at its Davie, Florida facility. Read More