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Medical Devices / Inspections and Audits

FDA Cites Repackager for Lack of Labeling Procedures

Nov. 12, 2019
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Alt Medical Devices’ Miami, Florida plant lacked procedures to control labeling activities and procedures for maintaining device history records to show that its devices were re-labeled and re-packaged according to specifications, FDA investigators found.

In a nine-item Form 483, they noted a history of documentation lapses and failure to establish quality control procedures.

For example, device history records for bio-microscopes re-labeled and re-packaged by the firm weren’t available for inspection, and inspectors said the firm lacked procedures for controlling and documenting acceptance activities such as incoming inspections, in-process functional testing for devices.

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