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 has cited a Dr. Reddy’s manufacturing site for a slew of violations, including deficient air supply in aseptic processing areas and a lack of microbiological testing. Read More
The FDA issued a warning letter to an active pharmaceutical ingredient distributor in Chongqing southwestern China for serious problems with quality and certificates of analyses (COAs). Read More
The FDA hit API drugmaker Alps Pharmaceutical of Gifu, Japan with a Form 483 for contamination, inadequate written procedures for cleaning and other violations. Read More
The FDA issued a warning letter to an API manufacturer in Gujarat, India for using untested water in manufacturing and for invalidating an out-of-specification test result without justification. Read More
The FDA issued a warning letter to OTC drug manufacturer Ningbo Pulisi Daily Chemical Products in Zhejiang, China for testing violations, including failure to fully test products prior to release. Read More
The FDA hit OTC drug manufacturer NeoBiotech Global of Auburn, Washington with a Form 483 for operating without a quality control unit and other serious violations. Read More
The FDA’s Office of Prescription Drug Promotion issued a warning letter to Metuchen Pharma over misleading claims in a print advertisement for its erectile dysfunction drug Stendra (avanafil). Read More