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Nippon Fine Chemical impeded a December 2015 inspection, the FDA said in a warning letter that claims employees blocked access to certain areas, refused to provide documents and prevented inspectors from taking photos. Read More
Violations of quality control standards for finished pharmaceuticals led to an FDA warning letter for Mappel Industria, a Brazil-based company. Read More
Hebei Yuxing Bio-Engineering, a Chinese producer of active pharmaceutical ingredients, has significant cGMP and data integrity issues at its manufacturing plant, the FDA said in a warning letter. Read More
Cheng Fong Chemical received a warning letter from the FDA for dirty equipment, poorly maintained facilities and improper investigations into possibly tainted batches of active pharmaceutical ingredients. Read More
Indian drugmaker Lupin is facing delays in expanding its presence in the U.S. market after an FDA inspection uncovered deficiencies at a company facility. Read More
Nicox, an international ophthalmic R&D company, announced it received a complete response letter related to its NDA for its cetirizine eye drop formulation AC-170. Read More
The Yangzhou Hengyuan Daily Chemical Plastic Co. received a warning letter after the FDA found that one of its drugs was missing the active ingredient and that the company was not testing finished batches of drug products. Read More