Topic: Form 483

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.

The FDA issued a 22-page, 11-observation Form 483 to Akorn’s Parsippany, New Jersey, plant following a five-week inspection.

The FDA continues to find issues with Dr. Reddy’s oncology formulation facility at Duvvada, one of three cited in a warning letter.

As the Chinese valsartan maker's shares tumble, the FDA fixed its import alert announcement to show that it applies to only one of its two sites in China.

The newest FDA Form 483 says Zhejiang Huahai Pharmaceutical made production changes to valsartan API without thoroughly testing them.