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Ongoing recalls of contaminated blood pressure drugs prompted the House Energy and Commerce Committee to call on Friday for a review of the FDA’s foreign drug inspection program. Read More
FDA investigators found serious violations at Sun Pharmaceutical’s Halol, Gujarat facility during a June 3-11 inspection including a substandard media fill. Read More
The FDA found termites, dead pests, impurities and other serious GMP violations at Bristol-Myers Squibb’s drug facility in Manati, Puerto Rico, during a Jan. 15-Feb. 6 inspection. Read More
The FDA hit Menlo Park, California-based Intersect ENT with a Form 483 over serious violations at its facility, including problems with environmental monitoring. Read More
The FDA hit Vida International’s drug manufacturing facility in Taoyuan City, Taiwan with a warning letter for serious quality violations including inadequate drug testing. Read More
The FDA cited bulk drug and dietary supplement manufacturer PLD Acquisitions following a Jan. 17-30 inspection of its Doral, Florida facility that turned up multiple equipment cleaning and maintenance issues. Read More
The FDA issued a warning letter to Spectrum Laboratory Products’ Gardena, California facility for releasing adulterated and misbranded drugs. Read More