Caraco Feels The Sting Of FDA's Accelerated Response To GMP Violations
FDA's fast action to seize drug products and ingredients at three Michigan facilities owned by Caraco Pharmaceutical Laboratories could reflect pressure from Reps. John Dingell and Bart Stupak to tighten controls on generic manufacturers
You may also be interested in...
MUMBAI - U.S. FDA toughened its stand on generic drug maker Caraco, ordering it to immediately stop distributing its drugs until the agency had assurance that the firm had complied with its good manufacturing practices
U.S. FDA Nails Ranbaxy On Charges Of Falsifying Data; Halts All Application Reviews From Paonta Sahib Plant
MUMBAI - India's largest drug maker Ranbaxy received a body blow after the U.S. Food and Drug Administration initiated a new regulatory action against the company's Paonta Sahib-based manufacturing plant in India. The drug regulator halted review of drug applications from the manufacturing plant due to evidence of falsified data and invoked the Application Integrity Policy
MUMBAI - U.S. FDA issued a warning letter to Caraco Pharmaceuticals, a subsidiary of India's Sun Pharmaceuticals, after the drug regulator found quality control lapses at its Detroit facilities, Curaco announced Nov. 3. U.S. FDA said the QC lapses conflicted with the company's standard operating procedures