FDA Hits Atlanta Devicemaker for Missing Records

August 16, 2019

Devicemaker Kids II was hit with a Form 483 over violations at its Atlanta, Georgia facility, including missing design control and investigation records.

The FDA inspected the facility from April 16-18 and found that the firm could not produce investigation records for nine complaints and there was no procedure in place for investigating them.

The firm also lacked procedures for design input, design output and design history files.

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