Baxter 483 Covers CAPA, Risk-Assessment Issues

September 12, 2014

Baxter has received a two-observation Form 483 for corrective and preventive action issues and problems with risk assessments.

The company initiated a CAPA in May 2013 after customer complaints of mismatched orders of total parenteral nutrition ingredients. The mismatch was due to software assigning an incorrect formula to patients.

Baxter revised a software code but did not upgrade products in the field, as it determined the risk was acceptable. However, the company incorrectly calculated the risk, according to the Oct. 30, 2013, form, which was recently released.

The FDA’s review of product risk-management found Baxter’s analysis “fails to include this hazard of patient/order mix-up; therefore, no risk control measures have been documented.” Risk-control measures incorporated into the revised software version did not exist in the previous version, the form notes.

In its risk assessment, the company also failed to consider that the scenario could result in an over-delivery of ingredients if one patient received another’s TPN order, FDA investigators found.

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