Pharmaceutical & Life Sciences News

FDA Warns Boehringer, V-SAB
Of Manufacturing Practice Violations

May 21, 2013, 9:52 PM

In separate warning letters posted online May 21, the Food and Drug Administration told Boehringer Ingelheim Pharma GmbH and V-SAB Medical Labs Inc. that FDA inspections revealed the companies had not complied with current good manufacturing practices (cGMPs).

FDA said that as a result of the inspections, products made by the companies were considered “adulterated” under the Federal Food, Drug, and Cosmetic Act.

The agency also told V-SAB that it is marketing unapproved new drugs.

Boehringer Ingelheim.

In a letter dated May 6, FDA told Boehringer Ingelheim that it found violations during an inspection of the Ingelheim am Rhein, Germany,...

To read the full article log in. To learn more about a subscription click here.