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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
The FDA hit TG United’s drug manufacturing facility north of Tampa, Florida with a warning letter for repeat water system and cleaning failures found during a lengthy inspection. Read More
Acting FDA Commissioner Ned Sharpless flagged the agency’s increased focus on data integrity violations — and a warning letter sent Tuesday to a Chinese OTC drugmaker over falsified quality control documents. Read More