FDA 483 - Polo Custom Products - June 22, 2021

Polo Custom Products, a device contract manufacturer in Monticello, Iowa, was cited for significant deficiencies during an FDA inspection. The observations primarily concern inadequate process validation, specifically issues with operational qualifications and equipment calibration. Additionally, the firm failed to adequately establish corrective and preventive action procedures and did not take action when test equipment was found to be out of calibration.