Device Re-Packager Lacks Procedures to Control Labeling, Device History

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.

In addition, the firm lacked supplier control procedures for monitoring and documenting approved suppliers for devices re-labeled and re-packaged. Written procedures that define requirements and methods for reportable events submitted to the FDA were also lacking, as were procedures for CAPA events and conducting quality audits, the 483 said.

Read the Alt Medical Devices Form 483 here: www.fdanews.com/11-07-19-altmedicaldevices483.pdf.