FDA Warns Boehringer, V-SAB Of Manufacturing Practice Violations

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, ...