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The facility failed to test incoming glycerin lots to verify identity and determine whether diethylene glycol or ethylene glycol was present, the agency said. Read More
The FDA has agreed to recognize drug and active pharmaceutical ingredient GMP inspections carried out by authorities in Belgium, Denmark, Finland, Latvia and Estonia, updating the 1998 mutual recognition agreement between the U.S. and the European Union. Read More
The FDA cited German drug manufacturer Pekana Naturheilmittel for cleaning violations and other problems observed at its Baden-Wurttemberg facility. Read More
The FDA cited OTC drug manufacturer Agropharma for violations at its Salinas, Puerto Rico facility, including inadequate conformance testing, batch records and quality control. Read More
Los Angeles, California OTC drugmaker Product Packaging West drew a warning letter from the FDA for current good manufacturing practice violations observed at its facility, including inadequate recordkeeping and component testing. Read More
“The absence of a hole in the tablet will significantly change the dissolution profile and cause out of specification dissolution rates that could adversely impact the therapeutic effect of the drug product,” the agency warned. Read More
The FDA hit Torrance, California, OTC drugmaker Medical Chemical for a variety of violations seen at its facility, including inadequate cleaning and validating of equipment. Read More
The FDA came down on another Mylan facility with a warning letter — this time in Morgantown, West Virginia — for CGMP violations similar to those previously observed at other company plants. Read More
The FDA cited an Actavis Laboratories facility in Davie, Florida, over quality violations observed during a July inspection, including shortcomings with laser drilling procedures. Read More