Dr. Reddy's racks up more repeat violations at Bachupally by Eric Palmer Friday, February 15, 2019 Dr. Reddy’s, which has been struggling to bring a number of its key plants up to FDA standards, has been unable to learn from past mistakes.
FDA uncovers data manipulation at Immunomedics plant making mAb by Eric Palmer Wednesday, February 13, 2019 The FDA uncovered data integrity issues at the Immunomedics plant in New Jersey where it makes the cancer drug for which it was issued a CRL.
Dr. Reddy’s Bachupally plant has a version of FDA deja vu by Eric Palmer Monday, February 11, 2019 Dr. Reddy’s reported that its formulation plant in Bachupally, India, has been cited by the FDA with 11 violations.
FDA finds more issues at Lupin plant cited in warning letter by Eric Palmer Tuesday, January 29, 2019 The FDA in 2017 ripped Indian drugmaker Lupin’s Indore plant for repeating mistakes. In a new visit, the FDA has again found problems.
FDA gets specific on data integrity rules—News of Note by Eric Palmer Thursday, December 13, 2018 The FDA has issued final guidance on handling data integrity and other GMP expectations.
Issues persist at Pfizer's Hospira injectables plant by Eric Palmer Wednesday, December 12, 2018 The most recent inspection of Pfizer's troubled injectables plant in McPherson, Kansas, found eight observations, seven of them repeats.
Mylan recalls all valsartan drugs—News of Note by Eric Palmer Thursday, December 6, 2018 Mylan has expanded its valsartan recall to all lots; a Japanese company is buying a Boehringer Ingelheim API plant, plus more manufacturing news.
FDA tags Mylan West Virginia plant with warning letter by Eric Palmer Tuesday, November 20, 2018 Mylan on Tuesday acknowledged that the FDA had issued a warning letter for its troubled Morgantown, West Virginia, manufacturing plant.
Samsung BioLogics, Gardasil and more—FiercePharmaAsia by Angus Liu Friday, November 16, 2018 Samsung BioLogics faces potential delisting; Merck will increase Gardasil supply to China; Chinese officials mulls new regulation for vaccine.
Repeat violations stack up at Dr. Reddy's cancer drug plant by Eric Palmer Thursday, November 15, 2018 Management at Dr. Reddy’s oncology drug plant isn’t getting the FDA's message. A recent inspection found five of eight observations were repeats.