B. Braun Gets 483 for Poor Inquiries into Batch Problems

The FDA found B. Braun’s investigations into leaky products to be lacking in detail, handing the drugmaker a Form 483. During a January to February inspection of the drugmaker’s Irvine, Calif., facility, the FDA was troubled by leaking presterile bioburden samples taken from three batches during August 2013.
Drug GMP Report