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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
The French National Agency for Medicines and Health Products Safety (ANSM) released a statement alleging serious violations of good manufacturing practices at Nandu Chemicals Industries, an India-based API maker. Read More
The FDA’s new Inspection Protocol Project is expected to increase the likelihood of a drug manufacturing facility undergoing a pre-approval inspection from the current 30 percent to a target of 50 percent. Read More
Mappel Industria, a Brazil-based company received a warning letter from the FDA due to significant violations of cGMP regulations for finished pharmaceuticals. Read More
Syntese has received a Form 483 after an inspection revealed sanitation, quality and laboratory control issues at the Denmark-based API maker. Read More