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The FDA sent out a volley of warning letters to three U.S. distributors of kratom products for sales of unapproved new drugs claiming effectiveness in treating opioid addiction and withdrawal. Read More
The agency found that the firm did not validate its cleaning procedures to make sure no cross contamination occurred in human drugs manufactured at the facility. Read More
A North Carolina drug manufacturing facility is in the hot seat after an October FDA inspection found it was producing topical human drugs and pesticides using the same equipment. Read More
The FDA is on track to complete standardized inspection agreements with every nation in the European Union next summer, one of the agency’s senior international officials said. Read More
The FDA hit API manufacturer Reine Lifescience with a warning letter for significant GMP violations observed during a November inspection of its facility in Gujurat, India. Read More
A North Carolina drug manufacturing facility is in the hot seat after an October FDA inspection found it was producing topical human drugs and pesticides using the same equipment. Read More
The FDA observed multiple deficiencies related to equipment and quality control during a November inspection of Douglas Manufacturing’s finished drug facility in Lincoln, Auckland. Read More
The FDA hit Pfizer subsidiary Pharmacia & Upjohn with a Form 483 for inadequate employee training, poor equipment maintenance practices and inadequate sample inspection procedures. Read More
The FDA hit Optikem with a Form 483 after the agency’s investigator observed unsanitary conditions and problems with records in an inspection of the firm’s Denver facility. Read More
The FDA cited API manufacturer CIL Isotope Separations after an inspection of its Xenia, Ohio facility revealed quality control issues, investigational deficiencies and other violations. Read More
Recent FDA warnings and untitled letters show the agency’s enforcement efforts for advertising and promotion are focused on product risk information and pre-approval promotions for investigational drug products, according to two Ropes and Gray attorneys. Read More