FDA Cites Florida Firm for Procedural and Calibration Mishaps

November 1, 2019

The FDA hit Naples, Florida devicemaker AcuLux with a Form 483 for its equipment calibration and CAPA procedures.

An agency inspection revealed that the firm’s corrective and preventive action procedure was incomplete, failing to include a requirement to verify and validate the effectiveness of CAPAs.

AcuLux also didn’t define the frequency of calibration or testing for equipment used in the assembly of its medical optical light sources, and lacked documentation for the calibration status of equipment used to measure light output of the optical light sources.

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