German devicemaker Moeller Medical received an FDA Form 483 for procedural failures related to suppliers, testing and design changes.

The company’s supplier procedures lack provisions requiring suppliers to notify it about changes in product or services if the suppliers are not currently under a quality agreement with Moeller, the form says.

Another observation relates to bioburden testing, which is required yearly for tube sets used with the company’s LiquoGuard product. Despite this requirement, no identification of bioburden organisms is required by company procedure or included on yearly test results, according to the Jan. 30 form, recently made available.

Meanwhile, the company’s procedure and template for design changes and change requests do not require documentation of the decision on whether a change requires validation. “There is no procedure requiring that design validation be performed using production units or their equivalents, and design validation documentation does not contain information requiring or verifying that production units were used,” the form says.

Moeller did not respond to a request for comment by press time.

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