B. Braun Hit With FDA Warning for Repeat Drug Manufacturing Violations

B. Braun Medical Inc. was hit with an FDA warning for repeatedly violating the FDA’s drug manufacturing requirements.

The Food and Drug Administration’s warning letter, posted online May 30, said the agency found current good manufacturing practice (cGMP) violations at B. Braun’s drug manufacturing facility in Irvine, Calif., during an inspection in 2016. Because the drug products made at the facility don’t conform to cGMP, they are considered adulterated under the Federal Food, Drug, and Cosmetic Act, the letter said. B. Braun Medical makes infusion therapy and pain management products.

Warning letters are a good indication of the ...