B.Braun Gets 483 for Poor Inquiries into Batch Problems

September 24, 2014

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. B.Braun investigated the issue but failed to review batch records and maintenance work orders for certain equipment.

The investigations stated that the presterile bioburden result met specification and the company concluded that there was no impact on the product. The batches were later released.

Another investigation into batches that failed assay and potency tests was inadequate. While the batches were rejected in January, the drugmaker didn’t determine the root cause and whether other batches could be impacted.

The FDA also chided B.Braun over various quality procedures.

The agency found B.Braun doesn’t perform an adequate 100 percent visual inspection for the detection of particulates in the 250 ml, 500 ml and 1 liter intravenous solutions in Excel brand bags. 

The company says it is working closely with the FDA to address the issues in the form and is “taking the appropriate actions to resolve any identified observations.”