Home » B. Braun Gets 483 for Poor Inquiries into Batch Problems
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.
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