FDA 483 - Pompano Precision Products, Inc. - April 24, 2019

Pompano Precision Products, Inc. in Pompano Beach, FL, a contract manufacturer, was cited for five observations during an FDA inspection. The inspection revealed significant deficiencies in their quality system, including unvalidated software and processes, inadequate statistical techniques for sampling, insufficient control over nonconforming products, and deficient corrective and preventive action procedures. Additionally, complaint investigation records lacked essential information.