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Pharmaceuticals / Inspections and Audits

FDA Issues Baxalta Form 483 for Records, Building Issues and Uncorrected Observations

Dec. 8, 2016

The FDA issued a Form 483 to Baxalta after an inspection revealed a litany of observations including two from an earlier inspection that were not corrected.

The current inspection revealed 81 complaints of broken vials, which were in addition to the 2014 inspection which cited 21 broken vial complaints.  In addition, methods used in investigations were not qualified for their intended use.

It was also determined that the contents of a container ready for distribution were not sampled to insure that they complied with labeling standards.

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