Mexico’s Glicerinas Industriales, which supplies drug components like glycerin to pharmaceutical manufacturers, was nailed with an FDA warning letter that cited the company for product testing ...

The FDA conducts approximately 3,000 foreign inspections annually in more than 90 countries. Despite advance notice, the FDA has found serious deficiencies more than twice the rate of domestic ...

Recent FDA inspections of two separate Dr. Reddy’s manufacturing plants in India resulted in one facility getting the all clear, with another receiving a notice of Voluntary Action Indicated (VAI).

The FDA conducts about 12,000 inspections annually in the U.S. and 3,000 in other countries. While U.S. companies often get surprise inspections, foreign companies usually receive advanced notice ...

The inspection, which spanned Aug. 25 to Sept. 16, found 14 “observations,” including that the company's “nanotainer”—a wee vial for collecting blood­—was an uncleared medical device.

On Wednesday, the Food and Drug Administration (FDA) said that it plans to expand unannounced inspections at foreign sites that produce food, essential medicines, and other medical products for ...

BOSTON, July 31 (Reuters) - The U.S. Food and Drug Administration has notified Genzyme Corp that it will re-inspect a key manufacturing plant because the biotechnology company did not take ...