Topic: Form 483

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.

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 reported that its formulation plant in Bachupally, India, has been cited by the FDA with 11 violations.

The FDA in 2017 ripped Indian drugmaker Lupin’s Indore plant for repeating mistakes. In a new visit, the FDA has again found problems.

The FDA has issued final guidance on handling data integrity and other GMP expectations.

The most recent inspection of Pfizer's troubled injectables plant in McPherson, Kansas, found eight observations, seven of them repeats.

Mylan has expanded its valsartan recall to all lots; a Japanese company is buying a Boehringer Ingelheim API plant, plus more manufacturing news.

Mylan on Tuesday acknowledged that the FDA had issued a warning letter for its troubled Morgantown, West Virginia, manufacturing plant.

Samsung BioLogics faces potential delisting; Merck will increase Gardasil supply to China; Chinese officials mulls new regulation for vaccine.

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.