The FDA slapped three drug manufacturers — including two Chinese firms — with warning letters after the agency’s inspections revealed a wide range of issues at the facilities, such as…
The FDA announced that it will take enforcement action against compounders using the unapproved bulk substance cesium chloride, partially granting a December 2017 petition by Public Citizen. Source: Drug GMP…
The FDA hit Eau Zone Huiles Et Fragrances with a Form 483 after an inspection determined the OTC manufacturer had numerous deficiencies at its Montreal, Quebec facility including cleaning, testing…
The FDA hit Surmasis Pharmaceutical of Des Moines, Iowa with a Form 483 after a February inspection revealed problems with laboratory records, computer systems and equipment inspections. Source: Drug GMP…
The FDA issued warnings to the following facilities in Australia, Korea, the European Union and the United States for deficiencies in records, documentation, GMPs, testing and validation: Source: Drug GMP…
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. Source: Drug GMP Report
The FDA issued a Form 483 to Noven Pharmaceuticals after observing numerous problems at the transdermal drug manufacturer’s Miami, Florida facility. Source: Drug GMP Report
The Trump administration is urging the Supreme Court to take up a case testing whether the FDA’s refusal to approve a warning label on drugs preempts state laws that may…
The FDA hit Pennsylvania drugmaker Bio-Pharm with a Form 483 after an agency inspection in January revealed poor equipment maintenance and quality control issues. Source: Drug GMP Report
The FDA slammed Cerno Pharmaceuticals for producing adulterated drugs at its Miami, Florida facility. Source: Drug GMP Report