Indian drugmaker Jubilant Generics drew an FDA warning letter over repeat quality violations and inadequate complaint investigations at a facility in the northern state of Uttarakhand. Read More
Mumbai-based drugmaker Lupin is in hot water with the FDA over violations at its API and finished-drug plant in Mandideep, Madhya Pradesh. Read More
Failure to establish validation procedures or to conduct risk analysis for its Cardiosave hybrid intra-aortic balloon pumps landed Datascope a nine-item Form 483 following a July 30 to Oct. 3, 2018 FDA inspection of its Maywah, New Jerse... Read More
Failure to identify actions needed to correct and prevent microbial contamination landed Nurses Assist an FDA Form 483 following an Oct. 15 to Oct. 25, 2018 inspection of the firm’s Haltom City, Texas facility. Read More
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