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The FDA issued a warning letter to a Costa Rican OTC drug manufacturer for testing and other violations. and , an inadequate stability program and risks of cross-contamination netted a Costa Rican OTC drug manufacturer a warning letter from the FDA. Read More
A Form 483 issued following an FDA inspection of Novartis subsidiary AveXis’ control testing laboratory — currently the focus of a data manipulation investigation by the agency — is raising concerns about the firm’s own investigation and when it knew about the data discrepancies. Read More
Arguments for inclusion of the nine substances on the list didn’t convince the agency that the products “could not be used, adapted, or diluted rather than compounded from bulk drug substances.” Read More
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